Pat (DrugBank: -)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 1128 |
| 13 | 多発性硬化症／視神経脊髄炎 | 1621 |
| 160 | 先天性魚鱗癬 | 13 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04287543 (ClinicalTrials.gov) | May 2021 | 21/2/2020 | Melatonin on Clock Genes in Parkinson's Disease | Effect of Melatonin Administration on the PER1 and BMAL1 Clock Genes in Patients With Parkinson's Disease | Parkinson Disease | Drug: Melatonin;Drug: Placebos | Instituto Mexicano del Seguro Social | NULL | Withdrawn | 20 Years | N/A | All | 0 | Phase 2;Phase 3 | Mexico |
| 2 | NCT04590612 (ClinicalTrials.gov) | January 2021 | 17/9/2020 | Improving Quality of Life in Early Parkinson's Disease | The Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease Patients | Parkinson Disease;Depression | Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet;Drug: Citalopram | Western University, Canada | NULL | Not yet recruiting | 50 Years | 80 Years | All | 30 | N/A | NULL |
| 3 | NCT04377945 (ClinicalTrials.gov) | December 1, 2020 | 4/5/2020 | Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components | A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components | Dyskinesia, Drug-Induced | Drug: Part 1, JM-010 component Group A;Drug: Part 1, JM-010 component Group B;Drug: Part 1, JM-010 component Group C;Drug: Part 1, Placebo Group;Drug: Part 2, JM-010 combination Group A;Drug: Part 2, JM-010 combination Group B;Drug: Part 2, Placebo Group;Drug: Part 2, JM-010 component Group C | Bukwang Pharmaceutical | NULL | Not yet recruiting | 18 Years | 80 Years | All | 188 | Phase 2 | United States |
| 4 | NCT04651153 (ClinicalTrials.gov) | December 2020 | 25/11/2020 | A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD) | A Multicenter, Participant-Blind, Investigator-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB7853 in Healthy Male Study Participants and Multiple Ascending Doses in Patients With Parkinson's Disease | Parkinson's Disease | Drug: UCB7853;Other: Placebo | UCB Biopharma SRL | NULL | Not yet recruiting | 18 Years | 80 Years | All | 64 | Phase 1 | NULL |
| 5 | EUCTR2019-003315-60-NL (EUCTR) | 10/11/2020 | 08/10/2020 | A study investigating the effect and safety of a new potential drug for Parkinson's disease patients. | A phase 1/2 study investigating the pharmacokinetics, safety and efficacy of a highly concentrated buccal formulation of apomorphine (APORON®) in subjects with Parkinson's Disease - Buccal apomorphine (APORON) administration | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go Product Name: APO-go® INN or Proposed INN: Apomorphine Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE Product Name: APORON INN or Proposed INN: APORON Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE | Criceto IKM B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 1;Phase 2 | Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT04620382 (ClinicalTrials.gov) | November 9, 2020 | 27/10/2020 | Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients | Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients | Neurogenic Orthostatic Hypotension;Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson Disease | Drug: Midodrine;Drug: Placebo pill;Device: Abdominal compression;Device: sham compression | Vanderbilt University Medical Center | NULL | Recruiting | 40 Years | 80 Years | All | 31 | Early Phase 1 | United States |
| 7 | EUCTR2019-002952-17-CZ (EUCTR) | 04/11/2020 | 12/10/2020 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 854 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 8 | NCT03903549 (ClinicalTrials.gov) | November 1, 2020 | 3/4/2019 | Initial Investigation of [18F]P17-059 in Parkinson's Disease Patients and Healthy Volunteers | A Positron Emission Tomography (PET) Study to Investigate [18F]D6-FP-DTBZ ([18F]P17-059) for Potential Use as a Radioligand for Vesicular Monoamine Transporter (VMAT2) | Parkinson Disease | Drug: [18F]P17-059 | Five Eleven Pharma, Inc. | NULL | Not yet recruiting | 45 Years | 90 Years | All | 26 | Phase 1 | United States |
| 9 | NCT04435431 (ClinicalTrials.gov) | October 29, 2020 | 15/6/2020 | A Clinical Study of Mesdopetam in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia | A Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's Disease | Parkinson Disease | Drug: Mesdopetam;Drug: Placebo | Integrative Research Laboratories AB | NULL | Recruiting | 30 Years | 79 Years | All | 140 | Phase 2 | United States |
| 10 | JPRN-jRCTs031200172 | 26/10/2020 | 26/10/2020 | Effects of Elobixibat administration in patients with Parkinson's syndrome complicated with chronic constipation | Multicenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study Investigating the Efficacy and Safety of Elobixibat in Patients with Parkinson's Disease Complicating Chronic Constipation. - CONST-PD | Parkinson's disease, chronic constipation Parkinson's syndrome,chronic constipation,Symptomatic constipation | Take 10mg of Elobixibat or placebo once a day before meal. After the 2-week screening period, the study drug will be started on the day of enrollment. | Hatano Taku | Mochida Pharmaceutical Co., Ltd.;EA Pharma Co., Ltd. | Recruiting | >= 20age old | Not applicable | Both | 100 | N/A | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2020-003796-17-GB (EUCTR) | 22/10/2020 | 01/09/2020 | A study to look at the effect of CST-103 or CST-139 on blood flow in the brain and on memory. | An Open-Label Brain Imaging and Cognition Study to Determine Changes in Cerebral Perfusion and Cognition After Oral Administration of CST-103 or CST-139 | Patients with Mild Cognitive Impairment or Parkinson’s Disease MedDRA version: 21.1;Level: LLT;Classification code 10009846;Term: Cognitive impairment;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Spiropent Product Name: Clenbuterol HCl Product Code: CST-103 INN or Proposed INN: CLENBUTEROL HYDROCHLORIDE Trade Name: Berachin Product Name: Tulobuterol Product Code: CST-139 INN or Proposed INN: Tolubuterol Hydrochloride Other descriptive name: TULOBUTEROL HYDROCHLORIDE | CuraSen Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | United Kingdom | ||
| 12 | NCT04334317 (ClinicalTrials.gov) | October 21, 2020 | 30/3/2020 | Effect of TAK-071 on Falls in Participants With Parkinson Disease (PD) | A Randomized, Double-blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of Falls | Parkinson's Disease | Drug: TAK-071;Drug: Placebo | Takeda | Michael J. Fox Foundation for Parkinson's Research | Recruiting | 40 Years | 85 Years | All | 64 | Phase 2 | United States |
| 13 | ChiCTR2000038852 | 2020-10-20 | 2020-10-07 | Study on the effect and mechanism of cognitive-cup-tapping-balance-training on fall prevention in community Parkinson's patients: a randomized controlled trial | Study on the effect and mechanism of cognitive-cup-tapping-balance-training on fall prevention in community Parkinson's patients: a randomized controlled trial | Parkinson's disease | dual task training group :cognitive-cup-tapping balance training;single task training group:-cup-tapping balance training;control group:education; | Shanghai University of Sport | NULL | Recruiting | 40 | 80 | Both | dual task training group :29;single task training group:29;control group:29; | N/A | china |
| 14 | NCT04380142 (ClinicalTrials.gov) | October 19, 2020 | 6/5/2020 | Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease | A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients | Parkinson's Disease (PD) | Drug: ABBV-951;Drug: Placebo for Levodopa/Carbidopa (LD/CD);Drug: Levodopa/Carbidopa (LD/CD);Drug: Placebo for ABBV-951 | AbbVie | NULL | Recruiting | 30 Years | N/A | All | 130 | Phase 3 | United States;Australia |
| 15 | ChiCTR2000037624 | 2020-10-01 | 2020-08-29 | Clinical efficacy of dopamine agonist Pramipexol in the treatment of cognitive impairment in PATIENTS with PD-RBD and its population pharmacokinetic study | Clinical efficacy of dopamine agonist Pramipexol in the treatment of cognitive impairment in PATIENTS with PD-RBD and its population pharmacokinetic study | Parkinson's disease | experimental group:Pramipexol + dopa hydrazine combination therapy;control group: dopa hydrazine; | Shanghai General Hospital | NULL | Recruiting | 18 | 85 | Both | experimental group:50;control group:50; | China | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | ChiCTR2000037239 | 2020-10-01 | 2020-08-27 | Construction and application of a diagnostic marker for Parkinson's disease based on gut microbiomics | Construction and application of a diagnostic marker for Parkinson's disease based on gut microbiomics | Parkinson's disease | Gold Standard:All patients satisfied the United Kingdom Parkinson's Disease Society Brain Bank criteria;Index test:Microbial gene detection chip; | Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 55 | 80 | Both | Target condition:500;Difficult condition:600 | China | |
| 17 | NCT04338997 (ClinicalTrials.gov) | October 2020 | 3/4/2020 | PK Study in Patients With Parkinson's Disease With IZD174 | An Open-label Phase 1b Study to Evaluate the Pharmacokinetics and Pharmacodynamics in Plasma and Cerebrospinal Fluid (CSF), Safety and Tolerability of Oral IZD174 in Patients With Parkinson's Disease | Parkinson Disease | Drug: IZD174 | Inflazome UK Ltd | NULL | Withdrawn | 45 Years | 75 Years | All | 0 | Phase 1 | NULL |
| 18 | NCT03665493 (ClinicalTrials.gov) | September 30, 2020 | 4/9/2018 | Dopamine Effect on Inhibitory Control | Dopamine Effect on Inhibitory Control | Idiopathic Parkinson's Disease | Drug: PD patients H&Y=1.5-2 Medications ON;Drug: PD patients H&Y=1.5-2 Medications OFF;Behavioral: Healthy age-matched controls;Drug: PD patients H&Y=3 Medications OFF;Drug: PD patients H&Y=3 Medications ON | Giovanni Mirabella | NULL | Recruiting | 40 Years | 70 Years | All | 102 | N/A | Italy |
| 19 | EUCTR2020-001175-32-GB (EUCTR) | 29/09/2020 | 07/08/2020 | Clinical study to evaluate the effect of opicapone 50 mg in the pain associated to Parkinson’s disease. | Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) | Parkinson's disease patients with wearing-off motor fluctuations andassociated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys INN or Proposed INN: Opicapone | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 4 | Portugal;Spain;Germany;Italy;United Kingdom | ||
| 20 | EUCTR2019-002949-38-DE (EUCTR) | 07/09/2020 | 21/01/2020 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 552 | Phase 3 | United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | ChiCTR2000035872 | 2020-09-01 | 2020-08-19 | Effect of repetitive transcranial magnetic stimulation on gait and balance function in patients with Parkinson's disease and Parkinson's syndrome | Effect of repetitive transcranial magnetic stimulation on gait and balance function in patients with Parkinson's disease and Parkinson's syndrome | Parkinson's disease and Parkinson's syndrome | Parkinson's disease observation group:Repetitive transcranial magnetic stimulation+Visual feedback balance training system+Digital treadmill ;Parkinson's disease control group:Visual feedback balance training system+Digital treadmill;Parkinson's syndrome observation group:Repetitive transcranial magnetic stimulation+Visual feedback balance training system+Digital treadmill;Parkinson's syndrome control group:Visual feedback balance training system+Digital treadmill ; | Gansu Provincial Hospital | NULL | Pending | 50 | 85 | Both | Parkinson's disease observation group:28;Parkinson's disease control group:28;Parkinson's syndrome observation group:28;Parkinson's syndrome control group:28; | China | |
| 22 | NCT04524351 (ClinicalTrials.gov) | August 14, 2020 | 11/8/2020 | Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Posiphen® in Subjects With Early Alzheimer's Disease (AD) or Early Parkinson's Disease (PD) | Alzheimer Disease;Parkinson Disease | Drug: Posiphen | Annovis Bio Inc. | Parexel | Recruiting | 45 Years | N/A | All | 68 | Phase 1;Phase 2 | United States |
| 23 | NCT04449484 (ClinicalTrials.gov) | August 4, 2020 | 23/4/2019 | Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease | A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI1341 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: MEDI1341;Other: Placebo | AstraZeneca | NULL | Recruiting | 40 Years | 85 Years | All | 36 | Phase 1 | United States |
| 24 | ChiCTR2000034323 | 2020-08-01 | 2020-07-02 | The effect and correlation of rehabilitation training mode combined with visual feedback balance system and digital treadmill on three-dimensional Gait kinematics and diffusion tensor imaging in patients with early and mid period Parkinson's disease | The effect of rehabilitation training mode combined with visual feedback balance system and digital treadmill on Gait kinematics and diffusion tensor imaging in patients with early and mid period Parkinson's disease | Parkinson's disease | experimental group:Combined Rehabilitation Training of visual feedback balance system and digital treadmill;control group:Traditional Gait Balance Rehabilitation Training; | Xianhui Feng | NULL | Pending | Both | experimental group:30;control group:30; | China | |||
| 25 | NCT04483479 (ClinicalTrials.gov) | July 30, 2020 | 20/7/2020 | Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety Roll-over Study (Rollover) | A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week Period | Parkinson Disease;Constipation | Drug: Active Investigational Treatment ENT-01 | Enterin Inc. | NULL | Recruiting | 30 Years | 90 Years | All | 50 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2019-002951-40-DE (EUCTR) | 29/07/2020 | 12/02/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 27 | NCT04630860 (ClinicalTrials.gov) | July 7, 2020 | 5/11/2020 | A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PD | A Randomized, Open-label, Multiple Ascending Dose Study in Patients With Advanced-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections | Parkinson Disease | Drug: LY03003 | Luye Pharma Group Ltd. | NULL | Recruiting | 18 Years | 80 Years | All | 30 | Phase 1 | China |
| 28 | EUCTR2019-002951-40-HU (EUCTR) | 02/07/2020 | 29/04/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 29 | NCT04193527 (ClinicalTrials.gov) | July 2020 | 2/12/2019 | A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients | A Multicentre, Phase 3, Clinical Study to Compare the Striatal Uptake of a Dopamine Transporter Radioligand, DaTSCAN™ Ioflupane (123I) Injection, After Intravenous Administration to Chinese Patients With a Diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, or Essential Tremor and to Healthy Controls | Parkinsonian Syndrome;Parkinson Disease(PD);Multiple System Atrophy (MSA);Progressive Supranuclear Palsy (PSP) | Drug: DaTSCAN™ Ioflupane (123I) Injection | GE Healthcare | PPD | Not yet recruiting | 40 Years | 80 Years | All | 172 | Phase 3 | China |
| 30 | JPRN-UMIN000040889 | 2020/06/24 | 24/06/2020 | Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease | Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease - Comparison of gastrointestinal function before and after LCIG therapy for Parkinson's disease | Parkinson's disease | Levodopa-carbidopa continuous infusion gel (LCIG) therapy | Fujita Health University School of MedicineDepartment of Gastroenterology | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 200 | Phase 4 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2019-002951-40-CZ (EUCTR) | 03/06/2020 | 25/02/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 32 | NCT04384666 (ClinicalTrials.gov) | June 2, 2020 | 8/5/2020 | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | Parkinson Disease | Drug: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection);Other: Neupro 4 mg / 24 Hr. Transdermal Patch | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 45 Years | All | 56 | Phase 1 | United States |
| 33 | EUCTR2019-002949-38-PL (EUCTR) | 13/05/2020 | 20/02/2020 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 34 | NCT04571164 (ClinicalTrials.gov) | May 11, 2020 | 21/9/2020 | A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD | A Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD | Parkinson Disease | Drug: LY03003(Rotigotine,extended-release microspheres);Drug: Placebo,extended-release microspheres | Luye Pharma Group Ltd. | Parexel | Recruiting | 30 Years | N/A | All | 294 | Phase 3 | China |
| 35 | EUCTR2019-002950-22-HU (EUCTR) | 06/05/2020 | 12/03/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease | A Phase 3, Double-Blind, Randomized, Placebo Controlled, Parallel Group, Flexible-Dose, 27 Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson’s Disease (TEMPO 2 Trial) | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 296 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT04459052 (ClinicalTrials.gov) | April 30, 2020 | 26/6/2020 | FDOPA PET and Nutritional Support in Parkinson's Disease | Phase II: Physiological Effects of Nutritional Support in Patients With Parkinson's Disease | Parkinson Disease;Idiopathic Parkinson Disease | Dietary Supplement: N acetyl cysteine;Drug: [F-18] Fluorodopa Positron Emission Tomography | Thomas Jefferson University | NULL | Active, not recruiting | 30 Years | N/A | All | 50 | Phase 2 | United States |
| 37 | EUCTR2018-002233-37-PL (EUCTR) | 23/04/2020 | 24/01/2020 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy | ||
| 38 | EUCTR2019-002951-40-ES (EUCTR) | 14/04/2020 | 06/03/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 39 | EUCTR2019-002949-38-ES (EUCTR) | 07/04/2020 | 28/02/2020 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 40 | ChiCTR2000029465 | 2020-04-06 | 2020-02-02 | Comparison of effects of sitagliptin and metformin on motor function and cognitive function in patients with Parkinson's disease complicated with type 2 diabetes | Comparison of effects of sitagliptin and metformin on motor function and cognitive function in patients with Parkinson's disease complicated with type 2 diabetes | Type 2 Diabetes | Sitagliptin group:Sitagliptin 100mg/d for 52 weeks;metformin group:metformin 1000-1500mg/d for 52 weeks; | Peking Union Medical College Hospital | NULL | Pending | 18 | 75 | Both | Sitagliptin group:20;metformin group:20; | Phase 4 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2020-000686-16-NL (EUCTR) | 26/03/2020 | 09/03/2020 | Validation of finger tapping in PD patients | Randomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson’s Disease patients. | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 125 Product Name: SINEMET Product Code: RVG 08740 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopamonohydraat Other descriptive name: CARBIDOPA MONOHYDRATE | Centre for Human Drug Research | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Netherlands | ||
| 42 | NCT04269642 (ClinicalTrials.gov) | March 19, 2020 | 13/1/2020 | SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease | Phase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's Disease | Early Parkinson's Disease | Drug: PT320 2.0mg Placebo;Drug: PT320 2.0 mg;Drug: PT320 2.5 mg | Peptron, Inc. | NULL | Recruiting | 40 Years | 75 Years | All | 99 | Phase 2 | Korea, Republic of |
| 43 | EUCTR2019-002949-38-CZ (EUCTR) | 04/03/2020 | 19/12/2019 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 44 | NCT04127695 (ClinicalTrials.gov) | March 3, 2020 | 9/10/2019 | A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's Disease | A Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ABBV-0805 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ABBV-0805;Drug: Placebo ABBV-0805 | AbbVie | NULL | Withdrawn | N/A | 85 Years | All | 0 | Phase 1 | United States;Puerto Rico |
| 45 | NCT04154072 (ClinicalTrials.gov) | February 27, 2020 | 4/11/2019 | A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease | Parkinson Disease | Drug: NLY01;Drug: Vehicle | Neuraly, Inc. | NULL | Recruiting | 30 Years | 80 Years | All | 240 | Phase 2 | United States;Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT04291859 (ClinicalTrials.gov) | February 26, 2020 | 28/2/2020 | Lu AF28996 in Patients With Parkinson's Disease (PD) | Interventional, Open-label, Exploratory Study, Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AF28996 in Patients With Parkinson's Disease | Parkinson Disease | Drug: Lu AF28996 | H. Lundbeck A/S | NULL | Recruiting | 45 Years | 75 Years | All | 10 | Phase 1 | Netherlands |
| 47 | EUCTR2019-002949-38-HU (EUCTR) | 06/02/2020 | 17/12/2019 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | Serbia;United States;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 48 | EUCTR2018-002234-21-GB (EUCTR) | 05/02/2020 | 04/07/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations | AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;United States;Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 49 | NCT04246437 (ClinicalTrials.gov) | February 4, 2020 | 25/1/2020 | [18F]F-DOPA Imaging in Patients With Autonomic Failure | [18F]F-DOPA Imaging in Patients With Autonomic Failure | Autonomic Failure;Pure Autonomic Failure;Parkinson Disease;Multiple System Atrophy;Dementia With Lewy Bodies | Drug: [18F]FDOPA;Drug: Carbidopa 200mg oral dose;Drug: Entacapone 400mg oral dose | Daniel Claassen | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 1 | United States |
| 50 | NCT04322227 (ClinicalTrials.gov) | January 23, 2020 | 29/1/2020 | Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects | Interventional, Randomized, Double-blind, Placebo-controlled Three-way Crossover Study Investigating the Pharmacodynamic Effects of Two Doses of Foliglurax Using Electroencephalography in Patients With Parkinson's Disease and in Healthy Subjects | Parkinson Disease;Healthy | Drug: Foliglurax 10 mg (treatment A);Drug: Foliglurax 30 mg (treatment B);Drug: Placebo (treatment C) | H. Lundbeck A/S | NULL | Terminated | 50 Years | 70 Years | All | 6 | Phase 1 | France |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT04220762 (ClinicalTrials.gov) | January 21, 2020 | 17/12/2019 | A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease Patients | A Clinical Study to Determine the Optimal Dose of WIN-1001X by Evaluating Its Efficacy and Safety in Patients With Early Parkinson's Disease: Double-blind, Randomized, Placebo-controlled, Multicenter, Phase II Study | Parkinson Disease | Drug: WIN-1001X;Drug: Placebo | Medi Help Line | NULL | Recruiting | 30 Years | N/A | All | 188 | Phase 2 | Korea, Republic of |
| 52 | NCT04127578 (ClinicalTrials.gov) | January 3, 2020 | 14/10/2019 | Phase 1/2a Clinical Trial of PR001A in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) | A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of PR001A in Patients With Parkinson's Disease With at Least One GBA1 Mutation | Parkinson Disease | Biological: PR001A;Drug: Methylprednisolone;Drug: Sirolimus;Drug: Prednisone | Prevail Therapeutics | NULL | Recruiting | 35 Years | 80 Years | All | 12 | Phase 1;Phase 2 | United States |
| 53 | NCT03446807 (ClinicalTrials.gov) | January 2020 | 20/2/2018 | Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism | Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism | Parkinson Disease;Multiple System Atrophy;Progressive Supranuclear Palsy | Drug: Droxidopa;Drug: Placebo Oral Tablet | Loma Linda University | H. Lundbeck A/S | Not yet recruiting | 50 Years | N/A | All | 32 | Phase 2 | United States |
| 54 | NCT04097080 (ClinicalTrials.gov) | December 15, 2019 | 18/9/2019 | Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease | Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease | Parkinson Disease | Drug: NBTX-001;Drug: Standard of Care | Nobilis Therapeutics Inc. | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 1 | Russian Federation |
| 55 | NCT04249544 (ClinicalTrials.gov) | December 3, 2019 | 28/1/2020 | Social Decision Making in Parkinson's Disease | Cognitive and Neural Mechanisms of Impaired Social Decision-Making in Parkinson's Patients Taking Dopamine Agonists | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Vanderbilt University Medical Center | United States Department of Defense | Recruiting | 45 Years | 80 Years | All | 60 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT04183634 (ClinicalTrials.gov) | December 3, 2019 | 28/11/2019 | An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine. | An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine. | Parkinson Disease | Drug: Rotigotine TTS (Test);Drug: Neupro (Reference) | Sandoz | NULL | Terminated | 18 Years | 80 Years | All | 31 | Phase 1 | Germany |
| 57 | NCT04191577 (ClinicalTrials.gov) | December 2, 2019 | 30/10/2019 | Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations | Parkinson Disease | Drug: CVN424 Low Dose;Drug: CVN424 High Dose;Drug: Placebo | Cerevance Beta, Inc. | NULL | Recruiting | 30 Years | 80 Years | All | 66 | Phase 2 | United States |
| 58 | NCT04044131 (ClinicalTrials.gov) | December 1, 2019 | 17/7/2019 | Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) and Parkinson's Disease (PD) Patients | A Phase 2, Randomized, Placebo Controlled Study to Evaluate the Efficacy, Tolerability and Safety of Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) And Parkinson's Disease (PD) Patients | Alzheimer Disease;Parkinson Disease | Drug: Metabolic Cofactor Supplementation;Drug: Sorbitol | Istanbul Medipol University Hospital | ScandiBio Therapeutics AB;Alanya Alaaddin Keykubat University;Sahlgrenska University Hospital, Sweden;KTH Royal Institute of Technology | Recruiting | 18 Years | N/A | All | 120 | Phase 2 | Turkey |
| 59 | ChiCTR1900027306 | 2019-11-15 | 2019-11-08 | Application of optical coherence tomography and detection of a-synuclein in tears in the diagnosis of Parkinson's disease | Morphological changes of retina in patients with Parkinson's disease and the role of a-synuclein in retinal damage | Parkinson's disease | Gold Standard:British brain bank Parkinson's disease diagnostic criteria;Index test:Application of optical coherence tomography to observe the retinal structure of the macular area, optic disc area and the expression level of a-synuclein in tears in the diagnosis of Parkinson's disease.; | The First Affiliated Hospital of Chengdu Medical College | NULL | Recruiting | Both | Target condition:85;Difficult condition:85 | China | |||
| 60 | NCT03924414 (ClinicalTrials.gov) | November 15, 2019 | 2/4/2019 | Trial of Parkinson's And Zoledronic Acid | TOPAZ: Trial of Parkinson's And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson's Disease | Parkinson Disease;Osteoporosis;Parkinsonism | Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj;Other: Placebo | California Pacific Medical Center Research Institute | National Institute on Aging (NIA);University of California, San Francisco;Duke University;University of Pittsburgh;Parkinson's Foundation | Recruiting | 60 Years | N/A | All | 3500 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT04175132 (ClinicalTrials.gov) | November 12, 2019 | 12/11/2019 | Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD) | Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-PXT012253 Investigating the Brain mGlu4 Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of Foliglurax in Healthy Subjects and Patients With Parkinson's Disease | Healthy;Parkinson Disease | Drug: foliglurax | H. Lundbeck A/S | NULL | Terminated | 50 Years | 70 Years | All | 6 | Phase 1 | Sweden |
| 62 | ChiCTR1900027210 | 2019-11-01 | 2019-11-05 | Effects of different anesthesia methods on postoperative delirium in patients with Parkinson's disease and biological markers of postoperative delirium in patients with Parkinson's disease | Effects of different anesthesia methods on postoperative delirium in patients with Parkinson's disease and biological markers of postoperative delirium in patients with Parkinson's disease | Delirium | 1:Total Intravenous Anesthesia;2:Balance Anesthesia; | Tsinghua University Yuquan Hospital | NULL | Recruiting | Female | 1:60;2:60; | China | |||
| 63 | ChiCTR1900026956 | 2019-10-21 | 2019-10-27 | Minimum alveolar concentration-awake of sevoflurane in patients with Parkinson's disease | Minimum alveolar concentration-awake of sevoflurane in patients with Parkinson's disease | Parkinson’s disease | Parkinson’s disease group:Sevoflurane induction;Non-Parkinson’s disease group:Sevoflurane induction; | The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China | NULL | Pending | 40 | 64 | Both | Parkinson’s disease group:30;Non-Parkinson’s disease group:30; | N/A | China |
| 64 | EUCTR2018-003337-15-ES (EUCTR) | 17/10/2019 | 30/04/2019 | A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease. | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease | Early Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Sun Pharma Advanced Research Company (SPARC) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 504 | Phase 2 | United States;Hungary;Czech Republic;Slovakia;Poland;Spain;India | |||
| 65 | NCT04157933 (ClinicalTrials.gov) | October 16, 2019 | 1/11/2019 | Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease | A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects With Established Parkinson's Disease | Parkinson's Disease | Drug: 009-A1;Drug: 009-A2;Drug: 009-A3;Drug: 009-A0;Drug: 009-B1 (active --> placebo) crossover;Drug: 009-B2 (placebo --> active) crossover | Alexza Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 35 | Phase 1 | Netherlands |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | EUCTR2018-002233-37-GB (EUCTR) | 11/10/2019 | 14/02/2019 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | ||
| 67 | NCT04575259 (ClinicalTrials.gov) | October 10, 2019 | 29/9/2020 | OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001 | Open Label Extension Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001 | Parkinson Disease Dementia | Drug: ANAVEX2-73 | Anavex Life Sciences Corp. | Anavex Australia Pty Ltd.;Anavex Germany GmbH | Recruiting | 50 Years | 85 Years | All | 120 | Phase 2 | Australia;Spain |
| 68 | NCT03987750 (ClinicalTrials.gov) | October 2019 | 12/6/2019 | Safinamide for Levodopa-induced Dyskinesia (PD-LID) | A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of 2 Doses of Safinamide Compared to Placebo in the Treatment of LID in PD Patients With Motor Fluctuations | Dyskinesia, Drug-Induced;Parkinson Disease | Drug: Safinamide Methanesulfonate 150mg;Drug: Safinamide Methanesulfonate 100mg;Drug: Safinamide Methanesulfonate matching placebo | Zambon SpA | NULL | Withdrawn | 30 Years | N/A | All | 0 | Phase 3 | NULL |
| 69 | EUCTR2018-002234-21-DE (EUCTR) | 23/09/2019 | 16/05/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations | AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia | ||
| 70 | NCT03959540 (ClinicalTrials.gov) | September 2019 | 23/4/2019 | Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease | A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease | Parkinson Disease | Drug: Opicapone;Drug: Levodopa (L-DOPA) + Standard care | Bial - Portela C S.A. | NULL | Not yet recruiting | 75 Years | N/A | All | 100 | NULL | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | NCT04075318 (ClinicalTrials.gov) | August 29, 2019 | 5/8/2019 | Study of UB-312 in Healthy Participants and Parkinson's Disease Patients | A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants With Parkinson's Disease | Parkinson Disease;Parkinsonism | Biological: UB-312;Biological: Placebo | United Neuroscience Ltd. | Centre for Human Drug Research, Netherlands;Worldwide Clinical Trials | Active, not recruiting | 40 Years | 85 Years | All | 62 | Phase 1 | Netherlands |
| 72 | EUCTR2018-002234-21-ES (EUCTR) | 21/08/2019 | 11/06/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations | AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia | |||
| 73 | ChiCTR1900025372 | 2019-08-18 | 2019-08-25 | Digital assessment of Parkinson's disease | Quantitative evaluation of drug response test in patients with Parkinson's disease and the influence of rehabilitation intervention on the evaluation of drug response and the exploration of related mechanisms | Parkinson's disease | 1:rehabilitation;1:take levodopa;30:Wear wearable devices; | Tianjin Huanhu Hospital | NULL | Recruiting | Both | 1:30;1:30;30:30; | China | |||
| 74 | NCT03881371 (ClinicalTrials.gov) | August 1, 2019 | 18/3/2019 | A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa | Parkinson Disease | Drug: Safinamide;Other: Placebo | Zambon SpA | NULL | Recruiting | 18 Years | N/A | All | 306 | Phase 3 | China |
| 75 | JPRN-UMIN000037421 | 2019/08/01 | 01/08/2019 | A study on improvement of cognitive function by istradefylline for parkinson disease | An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - A study on improvement of cognitive function by istradefylline for parkinson disease | Parkinson disease | Prescription istradefylline 20 mg for 1 month. If there are no side effects, We increase to 40 mg and prescribe for 2 months. The assessments will be made in all patients participating the study, patients with MMSE scores of 26 or more, patients with MMSE score of less than 26. | Ichinomiya Nishi Hospital | NULL | Recruiting | 40years-old | 85years-old | Male and Female | 25 | Not selected | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | NCT03956979 (ClinicalTrials.gov) | July 22, 2019 | 17/5/2019 | A Study in Parkinson's Disease in paTients With mOderate to seveRe dyskInesiA | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson's Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations of JM-010 | Dyskinesias | Drug: JM-010 group A;Drug: JM-010 group B;Drug: Placebos | Contera Pharma | Bukwang Pharmaceutical | Recruiting | 18 Years | 80 Years | All | 81 | Phase 2 | Germany |
| 77 | ChiCTR1900021708 | 2019-07-01 | 2019-03-05 | Study for the brain network mechanism of pramipexole in the treatment of tremor-type PD patients based on DRD3 Ser9Gly polymorphi | Study for the brain network mechanism of pramipexole in the treatment of tremor-type PD patients based on DRD3 Ser9Gly polymorphism | Parkinson's Disease | Healthy control group:No;tremor-dominant phenotype PD patients group:pramipexole; | Department of Neurology, Brain Hospital Affiliated to Nanjing Medical University | NULL | Pending | 50 | 70 | Both | Healthy control group:80;tremor-dominant phenotype PD patients group:80; | China | |
| 78 | NCT03977441 (ClinicalTrials.gov) | July 2019 | 12/5/2019 | the Efficacy and Safety of Agomelatine in the Patients With Parkinson's Disease | A Multicenter, Randomized, Double-blind, Placebo-controlled Study: Evaluation of the Efficacy and Safety of Agomelatine in the Treatment of Sleep Disorders and Depression in Patients With Parkinson's Disease | Parkinson Disease;Depression;Sleep Disorders;Circadian Rhythm Disorders | Drug: Agomelatine or PIacebo | Second Affiliated Hospital of Soochow University | NULL | Not yet recruiting | 30 Years | 75 Years | All | 240 | Phase 4 | NULL |
| 79 | EUCTR2018-003219-23-GB (EUCTR) | 28/06/2019 | 04/06/2019 | CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease) | CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease): A phase 3 randomised double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson’s disease - CHIEF-PD | This trial will investigate the effectiveness of Rivastigmine on prevention of falls in patients with Parkinson's disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rivastigmin Luye Transdermal Patches - 4.6mg/24h Product Name: Rivastigmin Luye Transdermal Patches - 4.6mg/24h Product Code: N/A INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) Trade Name: Rivastigmine Luye Transdermal Patch- 9.5mg/24h Product Name: Rivastigmine Luye Transdermal Patch- 9.5mg/24h INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) Product Name: Rivastigmine transdermal system 13.3 mg/24 h Product Code: RIV-TDS 13.3 mg/24 h INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) | University of Bristol | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United Kingdom | ||
| 80 | EUCTR2018-003337-15-HU (EUCTR) | 18/06/2019 | 12/04/2019 | A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease. | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease | Early Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Sun Pharma Advanced Research Company (SPARC) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 504 | Phase 2 | United States;Hungary;Slovakia;Poland;Spain;India | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | EUCTR2018-002234-21-CZ (EUCTR) | 14/06/2019 | 30/05/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations | AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia | |||
| 82 | EUCTR2018-003337-15-SK (EUCTR) | 05/06/2019 | 26/04/2019 | A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease. | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease | Early Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 | Sun Pharma Advanced Research Company (SPARC) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 504 | Phase 2 | United States;Hungary;Slovakia;Poland;Spain;India | ||
| 83 | JPRN-UMIN000036952 | 2019/06/04 | 04/06/2019 | A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. | A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. - A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. | Patients who are suspected Parkinson's disease or related disorders, including dementia with Lewy bodies, multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, frontotemporal lobe degeneration, vascular parkinsonism, drug-induced parkinsonism, normal pressure hydrocephalus, and others. | 18F-FDOPA, 11C-Raclopride PET | Nagoya City Rehabilitation Agency | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Not applicable | Japan |
| 84 | ChiCTR1900022534 | 2019-06-01 | 2019-04-15 | Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial | Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial | non-motor symptoms of Parkinson’s disease | entacapone group:Patients in the entacapone group will be administered entacapone (Novartis; import drug registration certificate number: H20160680), 10 times per day, 200 mg each time, for 3 weeks. ;pramipexole group:Patients in the pramipexole group will be administered pramipexole (Boehringer-Ingelheim; import drug registration certificate number: 20140918) , 3 times per day, 1 mg each time, for 3 weeks.; | Geriatric Hospital of Hainan | NULL | Pending | 40 | 75 | Both | entacapone group:194;pramipexole group:194; | N/A | China |
| 85 | JPRN-jRCTs031180248 | 29/05/2019 | 12/03/2019 | N/A | Intervention study for the effect of Istradefylline on adjustment of Levodopa in Parkinson's Disease - Istra adjust PD | Parkinson's disease | Arm with treatment of Istradefylline and levodopa Treatment with Istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of Istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 1. Dose reduction is possible if the patient has tolerability issues. Patients will visit every 4 weeks from the following day of Week0, and 50mg levodopa will be added of if CGI-S score >=4 every time. Dose reduction is possible if the patient has tolerability issues. Arm without treatment of Istradefylline 50mg levodopa will be added at Week 0. Patients will visit every 4 weeks from the following day of Week0, and 50mg levodopa will be added of if CGI-S score >=4 every time. Dose reduction is possible if the patient has tolerability issues. | Hatano Taku | Kyowa Kirin Co., Ltd | Recruiting | >= 30age old | <= 84age old | Both | 111 | N/A | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | NCT03971617 (ClinicalTrials.gov) | May 29, 2019 | 30/5/2019 | Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease | A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's Disease | Parkinson Disease | Drug: Hydrogen;Drug: Placebo oral tablet | Stony Brook University | NULL | Recruiting | 40 Years | 80 Years | All | 70 | Phase 2;Phase 3 | United States |
| 87 | NCT03693872 (ClinicalTrials.gov) | May 15, 2019 | 1/10/2018 | Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals | Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals | Parkinson Disease | Drug: Apomorphine;Drug: Dopaminergic Agonist + Apomorphine | Rennes University Hospital | NULL | Recruiting | 18 Years | N/A | All | 42 | N/A | France |
| 88 | NCT03671785 (ClinicalTrials.gov) | May 15, 2019 | 12/9/2018 | Study of the Fecal Microbiome in Patients With Parkinson's Disease | A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Parkinson's Disease | Parkinson Disease | Drug: PRIM-DJ2727;Drug: Placebo oral capsule | The University of Texas Health Science Center, Houston | Kelsey Research Foundation | Recruiting | 55 Years | 75 Years | All | 12 | Phase 1 | United States |
| 89 | NCT04293159 (ClinicalTrials.gov) | May 14, 2019 | 19/2/2020 | Effect of Probiotic on Constipation in Patients With Parkinson's Disease | Effect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's Disease | Parkinson Disease;Constipation | Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®) | University of Salerno | Roberto Erro;Maria Teresa Pellecchia;Antonella Santonicola;Carolina Ciacci | Recruiting | 18 Years | 75 Years | All | 30 | N/A | Italy |
| 90 | NCT03958708 (ClinicalTrials.gov) | May 13, 2019 | 14/5/2019 | Modulation of Gut Microbiota by Rifaximin in PD Patients | Modulation of Gut Microbiota by Rifaximin in PD Patients | Parkinson Disease;Inflammation | Drug: Rifaximin 550 MG | Taipei Medical University Shuang Ho Hospital | NULL | Recruiting | 45 Years | 70 Years | All | 20 | Phase 1;Phase 2 | Taiwan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | NCT04566341 (ClinicalTrials.gov) | May 4, 2019 | 11/8/2020 | Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease | Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease | Parkinson Disease;Parkinson | Device: OCT - TCE | Massachusetts General Hospital | NULL | Recruiting | 40 Years | 85 Years | All | 20 | United States | |
| 92 | NCT03840837 (ClinicalTrials.gov) | May 2, 2019 | 11/2/2019 | Cholinergic Neurotransmission in Mobility and Cognition in Parkinson Disease | Cholinergic Neurotransmission - A Common Underlying Mechanism of Cognitive and Gait Impairment in Parkinson Disease | Parkinson Disease | Drug: Rivastigmine transdermal patch | University of Maryland, Baltimore | National Institute on Aging (NIA) | Recruiting | 18 Years | N/A | All | 100 | Phase 4 | United States |
| 93 | EUCTR2019-000247-27-FR (EUCTR) | 02/05/2019 | 05/03/2019 | Study to demonstrate an at least equivalent performance of a new test in brain imaging test compared to the reference examination to establish the differential diagnosis between Parkinson's Disease and Essential Tremor. | Non-inferiority study of the molecular imaging of dopamine transporters using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to distinguish between Parkinson’s Disease and Essential Tremor. - DATTEP | Patients suffering from an essential tremor or with Parkinson's disease. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10015496;Term: Essential tremor;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: DaTSCAN 74 MBq/ml solution for injection Product Code: [18F] LBT-999 | ZIONEXA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Phase 3 | France | ||
| 94 | JPRN-JapicCTI-194763 | 22/4/2019 | 20/05/2019 | Safety and PK study of LY03003 | An open-label study in Japanese patients with Parkinson's disease to evaluate the safety, pharmacokinetics and preliminary efficacy of LY03003 following intramuscular injections and its comparative bioavailability to Rotigotine transdermal patch. | Parkinson's Disease | Intervention name : Rotigotine INN of the intervention : Rotigotine Dosage And administration of the intervention : LY03003 IM injections 14, 28 and 56 mg/week. Control intervention name : Rotigotine INN of the control intervention : Rotigotine Dosage And administration of the control intervention : Rotigotine transdermal patch applications 4.5, 9 and 18 mg/day. | Shandong Luye Pharmaceutical Co., Ltd./CMIC Co., Ltd. | NULL | complete | 20 | BOTH | 32 | Phase 1 | Japan | |
| 95 | EUCTR2018-002233-37-DE (EUCTR) | 17/04/2019 | 08/01/2019 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | NCT04420910 (ClinicalTrials.gov) | April 15, 2019 | 4/6/2020 | Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's Disease | Investigation of Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's Disease | Parkinson Disease;Balance;Muscle Strength;Mobility;Non-motor Symptoms | Other: Non-Motor Symptoms;Other: Balance;Other: Lower Limb Strength;Other: Functional mobility | Ankara Yildirim Beyazit University | NULL | Completed | 50 Years | 65 Years | All | 44 | Turkey | |
| 97 | NCT03661125 (ClinicalTrials.gov) | April 11, 2019 | 4/9/2018 | SRC Inhibition as a Potential Target for Parkinson's Disease Psychosis | A Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis. | Parkinson Disease Psychosis | Drug: Saracatinib;Drug: Placebo Oral Tablet | King's College London | AstraZeneca;King's College Hospital NHS Trust | Recruiting | 40 Years | N/A | All | 30 | Early Phase 1 | United Kingdom |
| 98 | NCT03841604 (ClinicalTrials.gov) | April 9, 2019 | 30/1/2019 | Effect of Safinamide on Parkinson's Disease Related Chronic Pain | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain | Idiopathic Parkinson Disease | Drug: Safinamide Methanesulfonate;Drug: Safinamide methanesulfonate matching placebo | Zambon SpA | NULL | Recruiting | 30 Years | N/A | All | 177 | Phase 4 | Austria;France;Germany;Italy;Spain |
| 99 | EUCTR2016-000657-12-GR (EUCTR) | 04/04/2019 | 11/01/2019 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: - Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: - Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden | ||
| 100 | NCT03877510 (ClinicalTrials.gov) | April 3, 2019 | 12/3/2019 | Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations | An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations | Parkinson Disease | Drug: IPX203 140 mg;Drug: IPX203 210 mg;Drug: IPX203 280 mg;Drug: IPX203 350 mg | Impax Laboratories, LLC | NULL | Enrolling by invitation | 40 Years | N/A | All | 300 | Phase 3 | United States;Czechia;France;Germany;Italy;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 101 | NCT03922711 (ClinicalTrials.gov) | March 26, 2019 | 17/4/2019 | A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease | A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe) | Parkinson Disease | Drug: Pridopidine;Drug: Placebo | Prilenia | NULL | Terminated | 30 Years | 85 Years | All | 23 | Phase 2 | United States |
| 102 | NCT04064983 (ClinicalTrials.gov) | March 14, 2019 | 19/8/2019 | Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Parkinson's Disease | Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) for Parkinson's Disease | Parkinson Disease | Drug: HB-adMSCs | Hope Biosciences | NULL | No longer available | 18 Years | N/A | All | United States | ||
| 103 | ChiCTR1900021760 | 2019-03-09 | 2019-03-08 | Effect-site concentration of remifentanil for I-gel insertion in male patients with Parkinson’s disease undergoing deep brain stimulator implantation during target-controlled infusion of propofol | Effect-site concentration of remifentanil for I-gel insertion in male patients with Parkinson’s disease undergoing deep brain stimulator implantation during target-controlled infusion of propofol | Parkinson’s disease | Parkinson’s disease:propofol and remifentanil;Non-Parkinson’s disease:propofol and remifentanil; | The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China | NULL | Recruiting | 40 | 64 | Male | Parkinson’s disease:25;Non-Parkinson’s disease:25; | N/A | China |
| 104 | EUCTR2017-005170-19-FI (EUCTR) | 06/03/2019 | 07/12/2018 | A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension Study | A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Renishaw Neuro Solutions Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Finland;Sweden | ||
| 105 | NCT03887884 (ClinicalTrials.gov) | March 5, 2019 | 1/3/2019 | Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) | Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's Disease | Parkinson's Disease | Drug: CVT-301;Drug: Sinemet | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 23 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 106 | NCT03845387 (ClinicalTrials.gov) | February 26, 2019 | 15/2/2019 | A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease. | A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease. | Parkinson Disease | Drug: KDT-3594;Drug: Pramipexole | Kissei Pharmaceutical Co., Ltd. | NULL | Active, not recruiting | 20 Years | 79 Years | All | 100 | Phase 2 | Japan |
| 107 | NCT03655236 (ClinicalTrials.gov) | February 18, 2019 | 18/8/2018 | PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease | Early Parkinson Disease | Drug: K0706;Other: placebo | Sun Pharma Advanced Research Company Limited | NULL | Recruiting | 50 Years | N/A | All | 504 | Phase 2 | United States;Hungary;Poland;Slovakia;Spain |
| 108 | NCT03968744 (ClinicalTrials.gov) | February 18, 2019 | 19/4/2019 | Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease | A Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep Study | Idiopathic Parkinson's Disease (at Later Stage) | Drug: Safinamide | Alain Kaelin | Clinical Trial Unit Ente Ospedaliero Cantonale | Recruiting | 18 Years | N/A | All | 23 | Phase 4 | Switzerland |
| 109 | NCT03413384 (ClinicalTrials.gov) | February 15, 2019 | 8/1/2018 | To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia | A Randomized, Double Blinded, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia | Parkinson's Disease Dementia | Drug: Ceftriaxone;Other: Placebo | BrainX Corporation | NULL | Recruiting | 50 Years | 80 Years | All | 106 | Phase 2 | Taiwan |
| 110 | NCT04510922 (ClinicalTrials.gov) | February 11, 2019 | 9/7/2020 | Lundbeck TOMs Orthostatic Hypotension | Technology-Based Objective Measures for Gait and Postural Assessment in Parkinson Disease Patients With Orthostatic Hypotension: Feasibility and Effect-Size Finding Study | Orthostatic Hypotension;Idiopathic Parkinson Disease | Drug: Droxidopa 100 MG [Northera] | Alberto Espay, MD, MSc | Lundbeck LLC | Recruiting | 30 Years | 80 Years | All | 12 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 111 | EUCTR2017-002426-20-AT (EUCTR) | 22/01/2019 | 03/12/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Zambon SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 177 | Phase 4 | Spain;Austria | |||
| 112 | EUCTR2018-002877-23-AT (EUCTR) | 21/01/2019 | 07/12/2018 | Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. | Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD | Social functioning in Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Syntocinon 40 IU/ml nasal spray INN or Proposed INN: Synthetic Oxytocin Other descriptive name: OXYTOCIN SYNTHETIC | Abteilung für Neurologie der Medizinischen Universität Innsbruck | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 76 | Phase 2 | Austria | ||
| 113 | NCT03840005 (ClinicalTrials.gov) | December 18, 2018 | 11/2/2019 | Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The UP Study | A Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial To Assess The Safety And Tolerability Of 30mg/kg Daily Ursodeoxycholic Acid (UDCA) In Patients With Parkinson's Disease (PD) | Parkinson's Disease | Drug: Ursonorm | Sheffield Teaching Hospitals NHS Foundation Trust | JP Moulton Charitable Foundation;PRO.MED.CS Praha a.s.;Clinical Trials Research Unit, University of Sheffield | Active, not recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | United Kingdom |
| 114 | NCT03942172 (ClinicalTrials.gov) | November 27, 2018 | 6/5/2019 | Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses | Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses | Parkinson Disease | Device: SpotOn balance glasses | SpotOn Therapeutics Ltd. | NULL | Suspended | 30 Years | N/A | All | 50 | N/A | Israel |
| 115 | NCT03733561 (ClinicalTrials.gov) | November 9, 2018 | 6/11/2018 | A Study to Assess Pharmacokinetic Profiles of LY03003 and Neupro | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | Parkinson Disease | Drug: LY03003;Drug: Neupro 4Mg/24Hr Transdermal Patch | Luye Pharma Group Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 40 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 116 | EUCTR2018-001887-46-GB (EUCTR) | 08/11/2018 | 19/06/2019 | Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study' | A Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial to assess the safety and tolerability Of 30mg/kg daily Ursodeoxycholic Acid (UDCA) in Patients with Parkinson’s Disease (PD) - Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study' | Parkinson’s disease (PD) MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Sheffield Teaching Hospitals NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United Kingdom | |||
| 117 | NCT03670953 (ClinicalTrials.gov) | November 6, 2018 | 12/9/2018 | A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor Fluctuations | A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease (Disorder) | Drug: IR CD-LD;Drug: IPX203 ER CD-LD;Other: IPX203 placebo;Other: IR CD-LD placebo | Impax Laboratories, LLC | NULL | Recruiting | 40 Years | N/A | All | 510 | Phase 3 | United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom |
| 118 | NCT04629404 (ClinicalTrials.gov) | November 5, 2018 | 5/11/2020 | A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of Multiple Intramuscular Doses of LY03003 in Patients With Early Parkinson's Disease | Parkinson Disease | Drug: LY03003;Drug: Placebo | Luye Pharma Group Ltd. | NULL | Completed | 30 Years | N/A | All | 32 | Phase 1 | China |
| 119 | EUCTR2016-002033-30-NL (EUCTR) | 31/10/2018 | 15/11/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | |||
| 120 | EUCTR2017-003415-19-ES (EUCTR) | 31/10/2018 | 20/08/2018 | A Clinical Study in Parkinson’s Disease Patients With Moderate to Severe Abnormal Movements to See If JM-010 is Effective and Safe/Tolerable. | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson’s Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations Of JM-010 | Parkinson’s Disease Patients With Moderate to Severe Dyskinesia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan | Contera Pharma | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | France;Spain;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 121 | EUCTR2017-002426-20-ES (EUCTR) | 19/10/2018 | 20/08/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE | Zambon SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 177 | Phase 4 | Spain | ||
| 122 | NCT03720418 (ClinicalTrials.gov) | October 17, 2018 | 16/10/2018 | Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease | A Phase I/II Safety and Dose Evaluation Study of OXB-102 in Patients With Bilateral Idiopathic Parkinson's Disease | Parkinson Disease | Drug: OXB-102;Other: Imitation Surgical Procedure (ISP) | Axovant Sciences Ltd. | Oxford BioMedica | Recruiting | 30 Years | 70 Years | All | 30 | Phase 1;Phase 2 | France;United Kingdom |
| 123 | NCT04451096 (ClinicalTrials.gov) | October 6, 2018 | 19/6/2020 | Probiotics-prebiotic Fiber Therapy in Parkinson's Disease Patients With Constipation | Probiotics-prebiotic Fiber Therapy Improved Bowel Opening Frequency and Whole Gut Transit Time in Parkinson's Disease Patients With Constipation: A Randomised Controlled Study | Parkinson Disease;Constipation | Dietary Supplement: Probiotics with prebiotic;Dietary Supplement: Placebo | National University of Malaysia | NULL | Completed | 18 Years | N/A | All | 48 | Phase 3 | Malaysia |
| 124 | EUCTR2018-000346-19-FI (EUCTR) | 03/10/2018 | 09/07/2018 | An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease. | A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1;Phase 2 | Finland;Sweden | ||
| 125 | NCT03703570 (ClinicalTrials.gov) | September 29, 2018 | 5/10/2018 | A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations | A Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing Preparations | Parkinson's Disease | Drug: KW-6356;Drug: Placebo | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | 80 Years | All | 502 | Phase 2 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 126 | NCT03229174 (ClinicalTrials.gov) | August 23, 2018 | 21/4/2017 | Brain Perfusion & Oxygenation in Parkinson's Disease With NOH | Evaluation of Brain Perfusion and Oxygenation in PD Patients With Neurogenic Orthostatic Hypotension: 4 Week Comparison of Droxidopa Versus Placebo | Parkinson Disease;Neurogenic Orthostatic Hypotension | Drug: Droxidopa;Drug: Placebo | William Ondo, MD | Lundbeck LLC | Recruiting | 18 Years | 85 Years | All | 28 | Phase 4 | United States |
| 127 | NCT03567447 (ClinicalTrials.gov) | August 17, 2018 | 21/5/2018 | Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH) | Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH) | Parkinson Disease;Falls Patient | Drug: Droxidopa;Other: Placebo | St. Joseph's Hospital and Medical Center, Phoenix | H. Lundbeck A/S;Arizona State University | Recruiting | 30 Years | 83 Years | All | 10 | Phase 2 | United States |
| 128 | ChiCTR1800016949 | 2018-08-01 | 2018-07-04 | Efficacy assessment and standard treatment of rasagiline in Chinese patients with early Parkinson's disease | Efficacy assessment and standard treatment of rasagiline in Chinese patients with early Parkinson's disease | Parkinson's disease | Rasagiline early start group:rasagiline-rasagiline;Rasagiline delay start group:placebo-rasagiline; | Beijing Hospital | NULL | Pending | 30 | 80 | Both | Rasagiline early start group:130;Rasagiline delay start group:130; | China | |
| 129 | JPRN-UMIN000033285 | 2018/08/01 | 05/07/2018 | The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial | The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial - The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease | Parkinson's disease | Oral bisphosphonate agent group: taking orally Minodronic Acid Hydrate (50mg) 1 tablet per 4 weeks Intravenous bisphosphonate agent group: injecting Zoledronic Acid (5mg) 1 ampule per 48 weeks | Department of Orthopaedic Surgery, Niigata University Medical and Dental Hospital | Department of Neurology, Nishi-Niigata Chuo Hospital | Pending | 50years-old | Not applicable | Male and Female | 100 | Not selected | Japan |
| 130 | ChiCTR1800017084 | 2018-08-01 | 2018-07-11 | Investigation of new approaches and technologies in the management of Parkinson's disease | The efficacy of Butylphthalide on cognitive impairment of patients with idiopathic PD and DBS patients: A Randomized, double-blind, placebo-controlled, multicenter trial | Parkinson's disease | Butylphthalide group:Butylphthalide, 2 capsules/time, 3 times/day, for 48 weeks;Control group:Placebo, 2 capsules/time, 3 times/day, for 48 weeks; | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | NULL | Recruiting | 18 | 80 | Both | Butylphthalide group:140;Control group:140; | Phase 4 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 131 | NCT04455555 (ClinicalTrials.gov) | August 1, 2018 | 28/6/2020 | Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's Disease | Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's Disease | Parkinson's Disease | Drug: LY03003( the name of rotigotine);Other: Placebo | Peking University Third Hospital | NULL | Completed | 18 Years | N/A | All | 294 | Phase 3 | China |
| 132 | EUCTR2017-005170-19-SE (EUCTR) | 30/07/2018 | 10/04/2018 | A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension Study | A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Renishaw Neuro Solutions Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Finland;Sweden | ||
| 133 | NCT03611569 (ClinicalTrials.gov) | July 25, 2018 | 26/7/2018 | Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease | Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease | Healthy;Parkinson Disease | Drug: Lu AF82422;Drug: Placebo | H. Lundbeck A/S | NULL | Recruiting | 18 Years | 80 Years | All | 84 | Phase 1 | United States |
| 134 | NCT03587168 (ClinicalTrials.gov) | July 20, 2018 | 3/7/2018 | The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's Disease | The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's Disease | Parkinson Disease | Other: the timed 360° turn test;Other: Berg Balance Scale;Other: Four Square Step Test;Other: Functional Reach Test;Other: Trunk Impairment Scale;Other: Timed Up and Go Test;Other: Hoehn and Yahr Scale;Other: Unified Parkinson's Disease Rating Scale | Gazi University | NULL | Completed | 40 Years | N/A | All | 86 | Turkey | |
| 135 | JPRN-jRCTs052180158 | 19/07/2018 | 25/03/2019 | The effect of rehabilitation robots for patients with Parkinson's disease. | A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient. | Parkinson's Disease;D010300 | Robot group: The participants performs twelve per a session, 2sessions per a week for 8 weeks. Control group: The participants receives balance exercise by physical therapist twice a week for 8 weeks. | Domen Kazuhisa | NULL | Recruiting | >= 40age old | <= 80age old | Both | 50 | N/A | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 136 | NCT03594656 (ClinicalTrials.gov) | July 15, 2018 | 11/7/2018 | Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease | Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial | Parkinson Disease | Drug: Ganoderma;Drug: Placebos | Xuanwu Hospital, Beijing | NULL | Recruiting | 30 Years | 80 Years | All | 288 | Phase 3 | China |
| 137 | NCT03624920 (ClinicalTrials.gov) | July 12, 2018 | 10/7/2018 | Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness | Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness | Parkinson Disease | Drug: THN102 Dosage A;Drug: THN102 Dosage B;Drug: THN102 Dosage C | Theranexus | NULL | Completed | 18 Years | 80 Years | All | 77 | Phase 2 | United States;Czechia;France;Germany;Hungary |
| 138 | NCT03774459 (ClinicalTrials.gov) | July 9, 2018 | 8/12/2018 | ANAVEX2-73 Study in Parkinson's Disease Dementia | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients With Parkinson's Disease With Dementia | Parkinsons Disease With Dementia | Drug: High dose ANAVEX2-73;Drug: Mid dose ANAVEX2-73;Drug: Placebo oral capsule | Anavex Life Sciences Corp. | Anavex Germany GmbH | Completed | 50 Years | 85 Years | All | 132 | Phase 2 | Australia;Spain |
| 139 | NCT03775538 (ClinicalTrials.gov) | July 5, 2018 | 11/10/2018 | Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical Study | A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients With Idiopathic Parkinson's Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002 | Parkinson Disease;Movement Disorders;Neuro-Degenerative Disease;Nervous System Diseases;Brain Diseases | Drug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery System | Herantis Pharma Plc. | Renishaw plc. | Completed | 35 Years | 75 Years | All | 15 | Phase 1;Phase 2 | Finland;Sweden |
| 140 | EUCTR2017-004335-36-ES (EUCTR) | 04/07/2018 | 11/04/2018 | A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients. | A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients. - A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 | Cognition in Parkinson’s Disease with dementia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ANAVEX2-73 INN or Proposed INN: ANAVEX2-73 Product Name: ANAVEX2-73 INN or Proposed INN: ANAVEX2-73 | Anavex Life Sciences Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | Spain | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 141 | NCT03521635 (ClinicalTrials.gov) | July 3, 2018 | 11/4/2018 | The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa | A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD) | Parkinson Disease | Drug: Pramipexole SR;Drug: Pramipexole IR | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 98 | Phase 4 | China |
| 142 | JPRN-UMIN000033409 | 2018/07/02 | 17/07/2018 | Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial. | Parkinson's disease | Pretreatment by heparinoid In the pretreatment group, heparinoid is applied daily to the sites (shoulder, upper arm, abdomen, thigh, buttocks on both sides) to be applied rotigotine transdermal patch from the beginning of 1 week before. The dose is one finger tip unit (about 0.5 g) for two palms. The period is 8 weeks. Non-pretreatment by heparinoid. The non-pretreatment group use rotigotine without using heparinoid. The period is 8 weeks. | Wakayama Medical University | NULL | Recruiting | 20years-old | 85years-old | Male and Female | 20 | Phase 1 | Japan | |
| 143 | JPRN-UMIN000033454 | 2018/07/01 | 20/07/2018 | A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient. | A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient. - A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient. | Parkinson's Disease | robot assisted balance training (RABT) The group is taken 40-minute / session, twice a week during 8-weeks. Total intervention sessions are 16. traditional balance training (TBT) The group is taken 40-minute / session, twice a week during 8-weeks. Total intervention sessions are 16. | Hyogo College of Medicine | NULL | Recruiting | 40years-old | 80years-old | Male and Female | 50 | Not selected | Japan |
| 144 | NCT03576638 (ClinicalTrials.gov) | July 2018 | 25/6/2018 | Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients | An Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's Disease | Parkinson Disease | Drug: Accordion Pill Carbidopa/Levodopa;Drug: Sinemet CR 25Mg-100Mg Extended-Release Tablet | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | N/A | All | 12 | Phase 2 | NULL |
| 145 | NCT03562494 (ClinicalTrials.gov) | June 28, 2018 | 16/5/2018 | VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1) | A Randomized, Sham Surgery Controlled, Double-blind, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Moderate to Advanced Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Biological: VY-AADC02;Other: Sham (Placebo) Surgery | Neurocrine Biosciences | Voyager Therapeutics | Recruiting | 40 Years | 75 Years | All | 85 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 146 | NCT03407378 (ClinicalTrials.gov) | June 26, 2018 | 15/1/2018 | A Study to Investigate a New Treatment in Patients With Parkinson's Disease | A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's Disease | Parkinson Disease | Drug: IPT803;Genetic: Optional pharmacogenetic assessment;Other: Questionnaires;Other: Optional Blood-Oxygen-level Dependent functionalMRI;Other: Motor Assessments before taking regular PD treatment;Other: Motor Assessments on regular PD treatment | Tools4Patient | NULL | Completed | 35 Years | N/A | All | 110 | Phase 1;Phase 2 | United States;Belgium;France |
| 147 | NCT03439943 (ClinicalTrials.gov) | June 13, 2018 | 13/2/2018 | Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease | Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease | Parkinson Disease | Drug: Lixisenatide;Drug: placebo | University Hospital, Toulouse | Cure Parkinson;Réseau NS-Park;EUCLID;Sanofi | Active, not recruiting | 40 Years | 75 Years | All | 156 | Phase 2 | France |
| 148 | EUCTR2017-004006-18-NL (EUCTR) | 07/06/2018 | 15/11/2017 | The effect of inhaled levodopa on the recovery from off periods in patients with Parkinson's disease | Therapeutic effects of an inhaled levodopa dry powder formulation on the recovery from off periods in patients with Parkinson's disease - Effectiveness of inhaled levodopa in Parkinson's disease | Parkinson's disease is a progressive neurodegenerative disorder characterized by a lack of dopamine production due to the loss of dopamine producing cells in the substantia nigra. This lack of dopamine causes disruption of motor circuits in the brain resulting in motor function impairments like tremor, rigidity and bradykinesia. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Levodopa powder for inhalation Product Code: Levodopa Cyclops INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: Madopar 125 mg, orodispersible tablet | Pharmaceutical Technology and Biopharmacy, University of Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Phase 2 | Netherlands | ||
| 149 | NCT03510572 (ClinicalTrials.gov) | June 4, 2018 | 17/4/2018 | Evaluation of [18F]PI-2620 as a Potential Positron Emission Computed Tomography Radioligand for Imaging Tau Protein in the Brain | Clinical Evaluation of [18F]PI-2620 Positron Emission Computed Tomography for Imaging Tau Protein in Patients With Tauopathies and Healthy Volunteers: Phase 0 Study | Healthy Volunteer;Alzheimer Disease;Frontotemporal Dementia;Parkinson Disease | Drug: [18F]PI-2620 | Asan Medical Center | Korea Health Industry Development Institute | Completed | 40 Years | 80 Years | All | 20 | Early Phase 1 | Korea, Republic of |
| 150 | EUCTR2018-000346-19-SE (EUCTR) | 04/06/2018 | 09/04/2018 | An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease. | A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1;Phase 2 | Finland;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 151 | NCT03891069 (ClinicalTrials.gov) | June 1, 2018 | 18/3/2019 | Feasibility of the AHA Exergame System in Parkinson's Disease Patients | Feasibility and Safety of the AHA Exergame System in Parkinson's Disease Patients: a Mixed Methods Study | Parkinson Disease | Device: AHA Exergame System | Campus Neurológico Sénior | University of Lisbon | Completed | 40 Years | 80 Years | All | 10 | N/A | Portugal |
| 152 | EUCTR2017-002780-17-ES (EUCTR) | 21/05/2018 | 12/02/2018 | Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the blood levels of Levodopa Administered as ND0612 via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Duodopa. | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;United States;Spain;Austria;Netherlands;Italy | ||
| 153 | NCT03589066 (ClinicalTrials.gov) | May 15, 2018 | 8/6/2018 | Pharmacokinetic Study of LY03003 in Patients With Parkinson's Disease | An Open-label, Randomized, Parallel-group Trial to Evaluate the Pharmacokinetics of Two Formulations of LY03003 After a Single Intramuscular Injection Administered to Patients With Parkinson's Disease | Parkinson Disease | Drug: LY03003 | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1 | United States |
| 154 | NCT03541356 (ClinicalTrials.gov) | May 8, 2018 | 5/4/2018 | Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal | A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of DCI to L-dopa Responsive Parkinson's Disease Patients | Parkinson's Disease | Combination Product: Placebo;Combination Product: L-dopa 35 mg;Combination Product: L-dopa 70mg;Combination Product: L-dopa 140 mg;Combination Product: L-dopa 70mg/carbidopa 7mg | Impel NeuroPharma Inc. | NULL | Completed | 40 Years | 80 Years | All | 32 | Phase 2 | Australia |
| 155 | NCT03587649 (ClinicalTrials.gov) | May 7, 2018 | 3/7/2018 | Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss | Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss in the Brain of Patients With Probable Alzheimer's Disease, Probable Parkinson's Disease (PD) Subjects as Compared to Healthy Volunteers (HV). | Alzheimer Disease;Parkinson Disease;Healthy Volunteers | Drug: [18F]MNI-1126 | Invicro | NULL | Completed | 18 Years | 55 Years | All | 12 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 156 | NCT04228887 (ClinicalTrials.gov) | May 4, 2018 | 5/8/2019 | Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease | Effects of Inspiratory Muscle Training on Postural Stability, Mobility, Activities of Daily Living, Quality of Life and Respiratory Function in Patients With Parkinson's Disease | Parkinson Disease | Diagnostic Test: Respiratory Muscle Strength;Device: Balance Training;Device: Inspiratory Muscle Training | Bezmialem Vakif University | NULL | Completed | 60 Years | 85 Years | All | 30 | N/A | Turkey |
| 157 | NCT03843944 (ClinicalTrials.gov) | May 1, 2018 | 12/2/2019 | Overnight Switch From Rasagiline To Safinamide | Overnight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety Study | Parkinson Disease | Drug: Safinamide | IRCCS San Raffaele | NULL | Completed | 30 Years | 80 Years | All | 20 | Phase 4 | Italy |
| 158 | EUCTR2017-002780-17-FR (EUCTR) | 26/04/2018 | 27/02/2018 | - | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;France;Spain;Austria;Netherlands;Italy | |||
| 159 | EUCTR2017-004253-16-AT (EUCTR) | 13/04/2018 | 27/02/2018 | Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-Motor symptoms (e.g.sleeping dirsorders, cognitive dysfunction, hallucinations, autonomic dysfunction,...) | Nabilone for non-motor symptoms in Parkinson’s disease: An open-label study to evaluate long-term safety and efficacy | Subject with non-Motor symptoms of Parkinson´s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Medizinische Universität Innsbruck, Universitätsklinik für Neurologie | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 3 | Austria | |||
| 160 | EUCTR2017-002780-17-IT (EUCTR) | 10/04/2018 | 04/11/2020 | study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusion | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson¿s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension - study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered | Parkinson¿s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa INN or Proposed INN: LEVODOPA Other descriptive name: levodopa | NEURODERM LTD. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;France;Spain;Austria;Netherlands;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 161 | EUCTR2016-003456-70-DE (EUCTR) | 04/04/2018 | 03/04/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomor | Sunovion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 162 | NCT03827746 (ClinicalTrials.gov) | April 1, 2018 | 31/1/2019 | The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients | The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients | Parkinson Disease;Kinesiophobia;Physical Activity;Balance;Falling | Other: Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy Scale | Istanbul Kültür University | Marmara University;Istanbul University-Cerrahpasa;Koç University | Completed | 40 Years | 85 Years | All | 60 | Turkey | |
| 163 | ChiCTR1800015331 | 2018-04-01 | 2018-03-23 | Dopaminergic Mechanisms of Temporal Working Memory in Parkinson's Disease | Dopaminergic Mechanisms of Temporal Working Memory in Parkinson's Disease | Parkinson's disease | de novo PD patients:levodopa 4 weeks;de novo PD patients:pramipexole 4 weeks;de novo PD patients:selegiline 4 weeks; | Institute of Psychology, Chinese Academy of Sciences | NULL | Recruiting | 50 | 80 | Both | de novo PD patients:50;de novo PD patients:50;de novo PD patients:50; | China | |
| 164 | NCT03648671 (ClinicalTrials.gov) | March 28, 2018 | 26/6/2018 | Pain in Parkinson's Disease With Motor Fluctuations. | Spontaneous and Evoked Pain in Parkinson's Disease With Motor Fluctuations: an Observational, Prospective, Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies. | Parkinson Disease | Drug: safinamide metansolfonato (12 weeks);Drug: rasagilina mesilato (12 weeks) | Universita di Verona | Azienda Ospedaliera Universitaria Integrata Verona | Unknown status | 18 Years | 80 Years | All | 48 | Italy | |
| 165 | NCT03419806 (ClinicalTrials.gov) | February 16, 2018 | 10/1/2018 | Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's Disease | Levodopa Pharmacokinetics in Patients With Parkinson's Disease and Symptom Fluctuation: A Phase I, Open-label, Randomized, Multicentre, Crossover Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa | Parkinson Disease | Drug: Infudopa i.v.;Drug: Infudopa s.c.;Drug: LCIG (Duodopa) | Vastra Gotaland Region | The Swedish Research Council;Dizlin Medical Design AB;Göteborg University | Completed | 30 Years | N/A | All | 25 | Phase 1 | Sweden |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 166 | EUCTR2016-000637-43-ES (EUCTR) | 06/02/2018 | 07/12/2017 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;United States;Canada;Spain;Austria;Germany;Italy;United Kingdom | ||
| 167 | EUCTR2016-003456-70-ES (EUCTR) | 06/02/2018 | 07/12/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 85 | Phase 3 | Spain;Austria;United Kingdom | ||
| 168 | EUCTR2016-000637-43-AT (EUCTR) | 01/02/2018 | 15/12/2017 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;France;Canada;Spain;Austria;Germany;United Kingdom;Italy | ||
| 169 | JPRN-UMIN000030930 | 2018/01/29 | 01/01/2019 | Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease. | Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease. - Effect of febuxostat and inosine on Parkinson's disease | Parkinson's disease | Administration of febuxostat 20 mg and inosine 500 mg twice a day for 58 days | StaGen Co. Ltd. | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 30 | Not selected | Japan |
| 170 | ChiCTR1800014542 | 2018-01-22 | 2018-01-20 | Up-down sequential testing of propofol - induced half-effective dose ( ed50 ) in patients with Parkinson's disease and non - Parkinson's disease | Up-down sequential testing of propofol - induced half-effective dose ( ed50 ) in patients with Parkinson's disease and non - Parkinson's disease | Parkinson's Disease | PD group:propofol;NPD group:propofol; | Xuanwu Hospital of CCMU | NULL | Recruiting | 18 | 65 | Both | PD group:40;NPD group:40; | China | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 171 | NCT03550183 (ClinicalTrials.gov) | January 10, 2018 | 11/5/2018 | Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's Disease | Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells | Parkinson's Disease | Biological: mesenchymal stem cells | Hebei Newtherapy BIo-Pharma technology Co., Ltd. | NULL | Enrolling by invitation | 40 Years | 80 Years | All | 20 | Phase 1 | China |
| 172 | EUCTR2016-003456-70-AT (EUCTR) | 04/01/2018 | 16/11/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 21.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;Italy;United Kingdom | |||
| 173 | EUCTR2017-000877-35-IT (EUCTR) | 04/12/2017 | 10/11/2020 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson's Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson's Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ31-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Product Name: Bavisant Product Code: [JNJ31-31001074] INN or Proposed INN: Bavisant dihydrochloride monohydrate Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate | BENEVOLENTAI BIO | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czechia;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy | ||
| 174 | NCT03944785 (ClinicalTrials.gov) | November 30, 2017 | 1/5/2019 | Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide) | A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)Tablets | Idiopathic Parkinson Disease | Drug: XADAGO (safinamide) | US WorldMeds LLC | NULL | Completed | 30 Years | 80 Years | All | 209 | United States | |
| 175 | EUCTR2016-002033-30-GB (EUCTR) | 27/11/2017 | 05/09/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 176 | NCT03194217 (ClinicalTrials.gov) | November 10, 2017 | 19/6/2017 | BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness | Dose Finding Phase IIb Study of Bavisant to Evaluate Its Safety and effiCacy in treAtment of exceSsive Daytime sleePiness (EDS) in PARkinson's Disease (PD). | Excessive Daytime Sleepiness;Parkinson Disease | Drug: BEN-2001;Drug: Placebo | BenevolentAI Bio | NULL | Completed | 50 Years | 80 Years | All | 244 | Phase 2 | United States |
| 177 | EUCTR2016-002033-30-HU (EUCTR) | 08/11/2017 | 19/09/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 178 | EUCTR2017-000877-35-DE (EUCTR) | 19/10/2017 | 04/09/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and effiCacy in treAtment of exceSsive daytime sleePiness (EDS) in PARkinson’s Disease (PD). CASPAR study. - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy | ||
| 179 | NCT04045678 (ClinicalTrials.gov) | October 10, 2017 | 30/7/2019 | A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's Disease | A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections | Parkinson Disease | Drug: LY03003 ( Rotigotine, extended-release microspheres);Drug: Placebo, extended-release microspheres | Luye Pharma Group Ltd. | Beijing Bozhiyin T&S Co., Ltd. | Completed | 18 Years | 75 Years | All | 30 | Phase 1 | China |
| 180 | NCT03250117 (ClinicalTrials.gov) | October 10, 2017 | 11/8/2017 | Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole | An Open-Label, Relative Bioavailability Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ropinirole Implants in Patients With Parkinson's Disease Switched From Oral Immediate-Release Ropinirole While on L-Dopa | Parkinson Disease | Drug: Ropinirole oral product;Drug: Ropinirole Implant | Titan Pharmaceuticals | NULL | Terminated | 30 Years | 80 Years | All | 3 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 181 | EUCTR2017-001673-17-FI (EUCTR) | 03/10/2017 | 29/08/2017 | A study to evaluate the safety and tolerability of IRL752 treatment inpatients with Parkinson's disease dementia. | A randomized, double-blind, placebo-controlled, multi-centre phase IIastudy evaluating the safety and tolerability of IRL752 in patients withParkinson's Disease Dementia | Dementia in Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;System Organ Class: 100000014717;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IRL752 INN or Proposed INN: IRL752 | Integrative Research Laboratories AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Finland;Sweden | ||
| 182 | NCT03257046 (ClinicalTrials.gov) | September 28, 2017 | 14/8/2017 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease | A Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's Disease | Parkinson Disease | Drug: ITI-214;Other: Placebo | Intra-Cellular Therapies, Inc. | NULL | Completed | 50 Years | N/A | All | 40 | Phase 1;Phase 2 | United States |
| 183 | EUCTR2015-004175-73-FI (EUCTR) | 27/09/2017 | 07/07/2016 | A clinical study to test the safety of CDNF by brain infusion in patients with Parkinson's disease. | A Phase I-II, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intermittent Bilateral Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Administered via an Investigational Drug Delivery System to Patients with Idiopathic Parkinson’s Disease (PD) of Moderate Severity. | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 17 | Phase 1;Phase 2 | Finland | ||
| 184 | NCT03295786 (ClinicalTrials.gov) | September 26, 2017 | 14/9/2017 | Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease | Phase 1-2, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Via an Investigational Drug Delivery System to Patients With Parkinson's Disease | Parkinson Disease;Movement Disorders;Neurodegenerative Diseases;Nervous System Diseases;Brain Diseases | Drug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery System | Herantis Pharma Plc. | Renishaw plc. | Completed | 35 Years | 75 Years | All | 17 | Phase 1;Phase 2 | Finland;Sweden |
| 185 | EUCTR2017-000192-86-AT (EUCTR) | 15/09/2017 | 10/08/2017 | Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-motor symptoms (e.g.sleeping disorders,cognitive dysfunction, hallucinations, autonomic dysfunction including urinary incontinence, constipation,...) | Nabilone for non-motor symptoms in Parkinson´s disease: A Randomized Placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal Study | Subjects with non-motor symptoms of Parkinson´s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Medizinische Universität Innsbruck, Universitätsklinik für Neurologie | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Austria | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 186 | EUCTR2016-003961-25-CZ (EUCTR) | 07/09/2017 | 15/05/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Hungary;Czech Republic;European Union;Canada;Spain;Australia;Germany;United Kingdom | ||
| 187 | NCT03272230 (ClinicalTrials.gov) | September 6, 2017 | 3/8/2017 | Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System | Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral Disease | Apathy;Frontotemporal Dementia;Parkinson Disease;Depressive Symptoms | Behavioral: ECOCAPTURE;Behavioral: Cognitive and Behavioral experimental tasks;Diagnostic Test: Neuropsychological assessment;Behavioral: ICM_APATHY_TASKS;Other: MRI;Biological: Neurohormonal mechanisms;Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's Disease | Institut National de la Santé Et de la Recherche Médicale, France | NULL | Recruiting | 40 Years | 85 Years | All | 135 | N/A | France |
| 188 | ChiCTR-INR-17012013 | 2017-09-01 | 2017-07-17 | Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease | Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease | Parkinson‘s disease, Depression | BTX-A:BOTOX Allergan;Placebo:0.9% Sodium Chloride Injection; | Shanghai Tongji Hospital, Tongji University | NULL | Pending | 18 | 80 | Both | BTX-A:40;Placebo:40; | China | |
| 189 | NCT03204929 (ClinicalTrials.gov) | August 14, 2017 | 28/6/2017 | Dose Escalation Study of Cu(II)ATSM in Parkinson's Disease | A Phase 1 Dose Escalation Study of Cu(II)ATSM Administered Orally to Patients With Early Idiopathic Parkinson's Disease | Parkinson Disease | Drug: Cu(II)ATSM | Collaborative Medicinal Development Pty Limited | NULL | Completed | 30 Years | N/A | All | 31 | Phase 1 | Australia |
| 190 | EUCTR2017-000877-35-CZ (EUCTR) | 09/08/2017 | 05/06/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 191 | EUCTR2017-000877-35-GB (EUCTR) | 08/08/2017 | 17/07/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | ||
| 192 | EUCTR2017-000877-35-ES (EUCTR) | 03/08/2017 | 09/06/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United Kingdom;United States;Czech Republic;Poland;Spain;Germany;Italy | ||
| 193 | ChiCTR-IPR-17011875 | 2017-08-01 | 2017-07-05 | Effects of Baduanjin Combined Balance Training on Gait and Posture Control of Patients with Mild and Moderate Parkinson's Disease | Effects of Baduanjin Combined Balance Training on Gait and Posture Control of Patients with Mild and Moderate Parkinson's Disease | Parkinson's Disease | Control group:Conventional drug therapy;Baduanjin group:Baduanjin aerobic exercise;Balance function training group:Balance function training group; | Affiliated Lianyungang Hospital of Xuzhou Medical University | NULL | Pending | 40 | 80 | Both | Control group:30;Baduanjin group:30;Balance function training group:30; | China | |
| 194 | NCT03178786 (ClinicalTrials.gov) | July 18, 2017 | 5/6/2017 | Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease | Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease | Parkinson Disease | Behavioral: PAT sessions | NYU Langone Health | NULL | Recruiting | 40 Years | 75 Years | All | 40 | N/A | United States |
| 195 | NCT03412513 (ClinicalTrials.gov) | July 17, 2017 | 21/1/2018 | Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease | Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled Trial | Overactive Bladder;Parkinson Disease | Drug: Mirabegron;Drug: Placebo | Seoul National University Hospital | NULL | Unknown status | 40 Years | 80 Years | All | 144 | Phase 4 | Korea, Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 196 | NCT03026231 (ClinicalTrials.gov) | July 15, 2017 | 11/1/2017 | Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients | A Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's Disease | Parkinson's Disease | Biological: PRIM-DJ2727;Drug: Placebo (for PRIM-DJ2727) | The University of Texas Health Science Center, Houston | Kelsey Research Foundation | Withdrawn | 45 Years | 70 Years | All | 0 | Phase 1;Phase 2 | United States |
| 197 | NCT03555292 (ClinicalTrials.gov) | July 12, 2017 | 24/4/2018 | 11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes | Safety and Diagnostic Performance of 11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes | Parkinson Disease | Drug: 11C-PiB | Oriental Neurosurgery Evidence-Based-Study Team | NULL | Recruiting | 18 Years | N/A | All | 200 | Phase 2 | China |
| 198 | EUCTR2017-000135-14-ES (EUCTR) | 07/07/2017 | 09/06/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany | ||
| 199 | NCT03185481 (ClinicalTrials.gov) | July 6, 2017 | 9/6/2017 | Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations | A PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | Parkinson's Disease With Motor Fluctuations | Drug: 1 mg QD to 15 mg QD PF-06649751;Drug: 3 mg QD to 15 mg QD PF-06649751;Drug: 7 mg QD to 15 mg QD PF-06649751;Drug: 15 mg QD PF-06649751;Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study);Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD | Pfizer | NULL | Terminated | 40 Years | 87 Years | All | 5 | Phase 2 | United States |
| 200 | NCT03162874 (ClinicalTrials.gov) | July 4, 2017 | 19/5/2017 | Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) | Parkinson Disease | Drug: Placebo oral capsule;Drug: PXT002331 - dose 1;Drug: PXT002331 - dose 2 | Prexton Therapeutics | NULL | Completed | 35 Years | 85 Years | All | 157 | Phase 2 | Austria;France;Germany;Italy;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 201 | EUCTR2016-003961-25-DE (EUCTR) | 30/06/2017 | 01/02/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom | ||
| 202 | NCT03195231 (ClinicalTrials.gov) | June 25, 2017 | 20/6/2017 | Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease | Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial. | Antidepressive Agents | Drug: Wuling Powder;Drug: Placebo | Beijing Hospital | Tongji Hospital;Shanghai Tong Ren Hospital;The First Hospital of Hebei Medical University | Not yet recruiting | 40 Years | N/A | All | 120 | Phase 4 | NULL |
| 203 | EUCTR2017-000135-14-GB (EUCTR) | 15/06/2017 | 17/03/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 204 | EUCTR2016-003961-25-ES (EUCTR) | 08/06/2017 | 27/04/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom | ||
| 205 | EUCTR2017-000135-14-DE (EUCTR) | 06/06/2017 | 10/03/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 206 | EUCTR2016-003961-25-HU (EUCTR) | 31/05/2017 | 03/04/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom | ||
| 207 | EUCTR2017-000135-14-IT (EUCTR) | 30/05/2017 | 04/11/2020 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | Studio di fase IIa, multicentrico, in doppio cieco, randomizzato, controllato verso placebo, a gruppi paralleli per valutare l'efficacia, la sicurezza e la tollerabilit¿ del trattamento orale con PXT002331 (foliglurax) della durata di 28 giorni nella riduzione delle complicazioni motorie dovute alla terapia con levodopa nei pazienti affetti da malattia di Parkinson che manifestano deterioramento da fine dose e discinesia indotta da levodopa (AMBLED) - AMBLED Study | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax | PREXTON THERAPEUTICS B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 208 | EUCTR2017-000135-14-AT (EUCTR) | 26/05/2017 | 08/03/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 209 | EUCTR2015-004507-23-FI (EUCTR) | 08/05/2017 | 30/03/2017 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 210 | NCT03119636 (ClinicalTrials.gov) | May 2017 | 6/4/2017 | Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's Disease | A Phase I/II, Open-Label Study to Assess the Safety and Efficacy of Striatum Transplantation of Human Embryonic Stem Cells-derived Neural Precursor Cells in Patients With Parkinson's Disease | Parkinson's Disease | Biological: NPC transplantation;Drug: Levodopa | Chinese Academy of Sciences | The First Affiliated Hospital of Zhengzhou University | Recruiting | 50 Years | 80 Years | All | 50 | Phase 1;Phase 2 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 211 | NCT02702076 (ClinicalTrials.gov) | May 2017 | 2/3/2016 | Apomorphine in Parkinson's Disease Patients With Visual Hallucinations | Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Continuous Subcutaneous Infusion in Parkinson's Disease Patients With Refractory Visual Hallucinations | Parkinson's Disease;Hallucinations, Visual | Drug: Apomorphine;Drug: Placebo | University Medical Center Groningen | NULL | Recruiting | 30 Years | N/A | All | 35 | Phase 2 | Netherlands |
| 212 | NCT03128450 (ClinicalTrials.gov) | April 15, 2017 | 9/2/2017 | A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient | A Single Arm, Open-Label,Pilot Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells Injection (ANGE-S003) Through Nasal Way Delivery to Patients With Parkinson's Disease | Parkinson Disease | Biological: human neural stem cell | Second Affiliated Hospital of Soochow University | NULL | Enrolling by invitation | 35 Years | 70 Years | All | 12 | Phase 2;Phase 3 | China |
| 213 | NCT03011476 (ClinicalTrials.gov) | April 11, 2017 | 27/12/2016 | Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease | Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease Characterized by Postural Instability and Gait Disturbance | Parkinson Disease | Drug: Donepezil;Drug: Placebos | Kyung Hee University Hospital | NULL | Unknown status | 40 Years | 75 Years | All | 20 | Phase 4 | Korea, Republic of |
| 214 | NCT03051607 (ClinicalTrials.gov) | April 10, 2017 | 9/2/2017 | Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease. | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off | Idiopathic Parkinson Disease | Drug: Tozadenant | Biotie Therapies Inc. | Acorda Therapeutics | Terminated | 30 Years | 80 Years | All | 66 | Phase 3 | United States;Canada;United Kingdom |
| 215 | JPRN-jRCTs051180185 | 07/04/2017 | 26/03/2019 | APISJ Study | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - APISJ Study | Parkinson's disease Parkinson's disease | In this research, the duration of evaluation will be 24 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by Istradefylline. | Takahashi Makio | Kyowa Kirin Co., Ltd. | Not Recruiting | >= 30age old | Not applicable | Both | 30 | N/A | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 216 | EUCTR2016-003961-25-GB (EUCTR) | 04/04/2017 | 16/02/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom | |||
| 217 | EUCTR2016-003456-70-GB (EUCTR) | 22/03/2017 | 26/01/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-BlindedRater to evaluate APL-130277 compared to s.c. Apomorphine in LevodopaResponsive Subjects with Parkinson's Disease Complicated by MotorFluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 21.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorp | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;Italy;United Kingdom | ||
| 218 | EUCTR2016-001575-71-ES (EUCTR) | 16/03/2017 | 17/01/2017 | A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASE | A 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE | Parkinson's Disease MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | France;United States;Spain;Israel;Germany | ||
| 219 | JPRN-UMIN000026492 | 2017/03/15 | 15/03/2017 | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - Intervention Study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease. | Parkinson's disease | In this research, the duration of evaluation will be 24 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline. | Osaka Red Cross Hospital | Clinical Research Center, Wakayama Medical University | Complete: follow-up complete | 30years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 220 | JPRN-jRCTs071180014 | 08/03/2017 | 29/01/2019 | ODYSSEI Study | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease - ODYSSEI Study | Parkinson's disease Parkinson's disease | Arm A: Treatment with Istradefylline combined with optimal medical therapy. Treatment with Istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of Istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. From the following day of Week 4, Optimal medical therapy including Istradefylline will be applied to each patient. Arm B: Optimal medical therapy without Istradefylline. Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than Istradefylline will be started at Week 0. After Week 4, Optimal medical therapy without Istradefylline will be applied to each patient. | Tsuboi Yoshio | Kyowa Kirin Co., Ltd. | Not Recruiting | >= 30age old | < 80age old | Both | 280 | N/A | N A;Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 221 | EUCTR2015-004507-23-HU (EUCTR) | 24/02/2017 | 04/01/2017 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 222 | NCT03068481 (ClinicalTrials.gov) | February 20, 2017 | 26/2/2017 | Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease | A Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease | Parkinson Disease | Drug: KDT-3594;Drug: Placebo | Kissei Pharmaceutical Co., Ltd. | NULL | Completed | 20 Years | 74 Years | All | 36 | Phase 1 | Japan |
| 223 | EUCTR2016-000657-12-IT (EUCTR) | 16/02/2017 | 08/02/2017 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: 000000 Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: 00000 Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 276 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Israel;Italy;United Kingdom;France;Canada;Singapore;Australia;Norway;Germany;Japan;Sweden | ||
| 224 | EUCTR2015-004344-19-DE (EUCTR) | 07/02/2017 | 27/09/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | ApoPharma | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Canada;Germany;United Kingdom | |||
| 225 | EUCTR2016-000657-12-DE (EUCTR) | 26/01/2017 | 17/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 226 | EUCTR2016-000657-12-PT (EUCTR) | 09/01/2017 | 25/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 2 | Portugal;United States;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Norway;Germany;Japan;Sweden | |||
| 227 | NCT03330470 (ClinicalTrials.gov) | January 1, 2017 | 17/10/2017 | Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease | Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease | Subjective Cognitive Impairment;Mild Cognitive Impairment;Parkinson Disease;Healthy Volunteers | Behavioral: exercise;Dietary Supplement: carnosine supplementation;Behavioral: stretching;Dietary Supplement: supplementation with placebo | Slovak Academy of Sciences | Comenius University;University Hospital Bratislava;National Cheng Kung University | Recruiting | 55 Years | 80 Years | All | 100 | N/A | Slovakia;Taiwan |
| 228 | EUCTR2016-001575-71-DE (EUCTR) | 23/12/2016 | 26/09/2016 | A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASE | A 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | France;United States;Spain;Israel;Germany | ||
| 229 | EUCTR2016-002033-30-BE (EUCTR) | 19/12/2016 | 21/11/2016 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 230 | NCT02906020 (ClinicalTrials.gov) | December 15, 2016 | 14/9/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients With Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant. | Parkinson's Disease | Drug: GZ/SAR402671;Drug: Placebo | Genzyme, a Sanofi Company | NULL | Active, not recruiting | 18 Years | 80 Years | All | 270 | Phase 2 | United States;Austria;Canada;France;Germany;Greece;Israel;Italy;Japan;Norway;Portugal;Singapore;Spain;Sweden;Taiwan;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 231 | JPRN-UMIN000024859 | 2016/12/14 | 16/11/2016 | The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. | The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. - The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. | Parkinson's disease | Switching from Dopamine agonist to Zonisamide. Intervention period of 12 weeks. | Medical Corporation Abe Neurology Clinic | NULL | Complete: follow-up continuing | 30years-old | Not applicable | Male and Female | 50 | Not applicable | Japan |
| 232 | ChiCTR2000037957 | 2016-12-01 | 2020-09-07 | Clinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's disease | Clinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's disease | Deep brain stimulation in patients with Parkinson's disease | Experimental group:conscious sedation with dexmedetomidine;control group:Pump in normal saline; | Shanghai Jing'an District Central Hospital | NULL | Completed | 45 | 75 | Both | Experimental group:27;control group:9; | China | |
| 233 | NCT02941822 (ClinicalTrials.gov) | December 2016 | 5/9/2016 | Ambroxol in Disease Modification in Parkinson Disease | A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients With Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease | Parkinson Disease | Drug: Ambroxol | University College, London | The Cure Parkinson's Trust | Completed | 40 Years | 80 Years | All | 23 | Phase 2 | United Kingdom |
| 234 | EUCTR2016-002033-30-FR (EUCTR) | 29/11/2016 | 12/01/2017 | A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;France;Hungary;Canada;Belgium;Spain;Denmark;Israel;Netherlands;United Kingdom;Sweden | |||
| 235 | JPRN-UMIN000024536 | 2016/11/28 | 25/10/2016 | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. - ODYSSEI Study(Onset of Dyskinesia and Safety/Efficacy of Istradefylline) | Parkinson's disease | Treatment with istradefylline combined with optimal medical therapy. Treatment with istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. From the following day of Week 4, Optimal medical therapy including istradefylline will be applied to each patient. Optimal medical therapy without istradefylline. Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than istradefylline will be started at Week 0. After Week 4, Optimal medical therapy without istradefylline will be applied to each patient. | Fukuoka University | NULL | Complete: follow-up complete | 30years-old | 80years-old | Male and Female | 280 | Not applicable | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 236 | EUCTR2015-004912-39-ES (EUCTR) | 25/11/2016 | 17/05/2016 | A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THEEFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | Parkinson's Disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | France;United States;Spain;Germany;Japan;United Kingdom | ||
| 237 | EUCTR2016-000102-11-NL (EUCTR) | 23/11/2016 | 08/11/2016 | Trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations. | Randomized, double-blind, placebo-controlled trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations. - Apomorphine in PD patients with visual hallucinations: a RCT | Parkinson's disease patients with refractory visual hallucinations MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: APO-go Product Name: Apomorphine | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2;Phase 3 | Netherlands | |||
| 238 | NCT02847442 (ClinicalTrials.gov) | November 23, 2016 | 21/7/2016 | Efficacy and Safety of Opicapone in Clinical Practice | Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations | Parkinson's Disease With Wearing-off Motor Fluctuations | Drug: BIA 9-1067;Drug: levodopa/dopa decarboxylase inhibitor | Bial - Portela C S.A. | NULL | Completed | 30 Years | N/A | All | 518 | Phase 4 | Germany |
| 239 | EUCTR2016-000657-12-SE (EUCTR) | 09/11/2016 | 12/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden | ||
| 240 | NCT03531060 (ClinicalTrials.gov) | November 8, 2016 | 10/4/2018 | A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia | A Randomised, Double-blind, Placebo-controlled, Phase Ib Study Evaluating the Safety and Tolerability of IRL790 in Patients With Parkinson's Disease (PD) Experiencing Levodopa (L-Dopa) Induced Dyskinesia (LID). | Parkinson Disease | Drug: IRL790;Drug: Placebo | Integrative Research Laboratories AB | NULL | Completed | 50 Years | 85 Years | All | 15 | Phase 1;Phase 2 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 241 | EUCTR2016-002033-30-ES (EUCTR) | 03/11/2016 | 25/08/2016 | A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;France;Canada;Belgium;Spain;Denmark;Israel;Netherlands;Sweden | ||
| 242 | ChiCTR-IPR-16009395 | 2016-11-01 | 2016-10-14 | Clinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stage | Clinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stage | Parkinson’s disease | Butylphthalide group and Control group:Butylphthalide 200mg/time(2 capsules) , three time/day, for 24 weeks;Control:No treatment; | The Second Affiliated Hospital of Soochow University | NULL | Pending | 35 | Both | Butylphthalide group and Control group:36;Control:36; | China | ||
| 243 | NCT02857244 (ClinicalTrials.gov) | November 2016 | 25/7/2016 | A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients | A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients | Parkinson's Disease | Drug: Duloxetine;Drug: Donepezil;Drug: Modafinil | University of Chicago | NULL | Withdrawn | 18 Years | 100 Years | All | 0 | Phase 2 | United States |
| 244 | EUCTR2015-001786-10-DE (EUCTR) | 24/10/2016 | 07/04/2016 | A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease. | A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Germany;United Kingdom | |||
| 245 | EUCTR2016-000657-12-ES (EUCTR) | 20/10/2016 | 24/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: NA Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: NA Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 276 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 246 | NCT02871427 (ClinicalTrials.gov) | October 20, 2016 | 15/8/2016 | Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder | An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder | Lewy Body Dementia;Dementia With Lewy Bodies;Parkinson's Disease Dementia;Visual Hallucinations;REM Sleep Behavior Disorder | Drug: Nelotanserin | Axovant Sciences Ltd. | NULL | Terminated | 50 Years | N/A | All | 80 | Phase 2 | United States |
| 247 | NCT02847650 (ClinicalTrials.gov) | October 17, 2016 | 25/7/2016 | Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASE | Parkinson Disease | Drug: Placebo;Drug: PF-06649751 | Pfizer | NULL | Terminated | 45 Years | 80 Years | All | 57 | Phase 2 | United States;France;Germany;Israel |
| 248 | EUCTR2015-002571-24-GB (EUCTR) | 14/10/2016 | 12/02/2019 | A Pilot Study to Evaluate the Safety, Tolerability (any side effects of the drug) and Pharmacodynamic (biochemical and physiological effects of drugs). The effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease. | A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease - AiM-PD | Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Joint Research Office | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United Kingdom | |||
| 249 | NCT02728843 (ClinicalTrials.gov) | October 12, 2016 | 31/3/2016 | Study of Parkinson's Early Stage With Deferiprone | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Deferiprone;Drug: Placebo | ApoPharma | NULL | Completed | 18 Years | 80 Years | All | 140 | Phase 2 | Canada;France;Germany;United Kingdom |
| 250 | EUCTR2016-002391-27-GB (EUCTR) | 07/10/2016 | 04/08/2016 | Opicapone in clinical practice (OPTIPARK) | This action will amend the information submitted in this data field for all relevant applications. Please refer to the guidance under the Amendment tab and consider whether further notification to review bodies is required. - Opicapone in clinical practice (OPTIPARK)_V1 | Parkinson's disease (PD) patients with wearing-off motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 4 | Germany;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 251 | EUCTR2016-002391-27-DE (EUCTR) | 05/10/2016 | 05/08/2016 | OPTIPARK | Efficacy and safety of opicapone in clinical practice in Parkinson’s Disease patients with wearing-off motor fluctuations | Parkinson's disease (PD) patients with wearing-off motor fluctuations;Therapeutic area: Not possible to specify | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 4 | Germany;United Kingdom | |||
| 252 | NCT02935842 (ClinicalTrials.gov) | October 1, 2016 | 18/8/2016 | Evaluation of Intensive Language Therapy | Effectiveness of High-frequency Specific Speech Therapy on Verbal Fluency Decline and/ or Verbal Apraxia in Patients With Parkinson's Disease With and Without Deep Brain Stimulation (DBS) - a Randomized Controlled Single-blinded Trial | Parkinson's Disease | Other: Specific SL-therapy;Other: Rhythmic Balance-Movement Training (rBMT) | University Hospital, Basel, Switzerland | NULL | Completed | 45 Years | 80 Years | All | 38 | N/A | Switzerland |
| 253 | NCT02940912 (ClinicalTrials.gov) | October 2016 | 14/10/2016 | Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease | Double Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease | Parkinson Disease | Drug: Apomorphine;Drug: Placebo | Clinique Beau Soleil | NULL | Recruiting | 35 Years | 90 Years | All | 45 | Phase 4 | France |
| 254 | NCT02538315 (ClinicalTrials.gov) | October 2016 | 25/8/2015 | Using [18F]FDOPA PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease Patients | Using 3,4-dihydroxy-6-[18F]-Fluoro-l-phenylalanine ( [18F]FDOPA) PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease Patients | Parkinson`s Disease | Drug: [18F]FDOPA PET/CT | University of Saskatchewan | University of Manitoba | Recruiting | 18 Years | N/A | All | 30 | N/A | Canada |
| 255 | JPRN-UMIN000024312 | 2016/09/20 | 25/05/2017 | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. | Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis | Treatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeks | Tsukuba International Clinical Pharmacology Clinic | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 12 | Not selected | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 256 | NCT02688465 (ClinicalTrials.gov) | September 5, 2016 | 18/2/2016 | Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE). | Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE). | Parkinson's Disease | Drug: Apomorphine | Fondation Ophtalmologique Adolphe de Rothschild | NULL | Terminated | 18 Years | N/A | All | 15 | Phase 4 | France |
| 257 | NCT02782481 (ClinicalTrials.gov) | August 2016 | 22/5/2016 | A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations | A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations | Parkinson's Disease | Drug: ND0612;Drug: Placebo | NeuroDerm Ltd. | NULL | Withdrawn | 30 Years | 80 Years | All | 0 | Phase 3 | Israel |
| 258 | NCT02365870 (ClinicalTrials.gov) | August 2016 | 11/2/2015 | Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment | Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment | Anxiety Disorders;Parkinson Disease | Drug: rotigotine transdermal patch;Drug: placebo | Johns Hopkins University | National Institute on Aging (NIA) | Terminated | 21 Years | 89 Years | All | 4 | Phase 4 | United States |
| 259 | NCT02789592 (ClinicalTrials.gov) | July 2016 | 31/5/2016 | Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease | A Randomized Double-Blind, Double-Dummy, Crossover Study to Evaluate the Efficacy and Safety of Prolonged-Release Melatonin and Clonazepam in Patients With Rapid Eye Movement (REM) Sleep Behavior Disorder in Parkinson Disease | REM Sleep Behavior Disorder;Parkinson Disease | Drug: Melatonin PR;Drug: Clonazepam;Drug: Melatonin PR placebo;Drug: Clonazepam placebo | Seoul National University Hospital | Kuhnil Pharmaceutical Co., Ltd. | Not yet recruiting | 30 Years | N/A | Both | 30 | Phase 2 | Korea, Republic of |
| 260 | NCT02452723 (ClinicalTrials.gov) | July 2016 | 18/5/2015 | A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease | A Single Arm, Open-Label Phase 1 Study to Evaluate the Safety and Tolerability of ISC-hpNSC Injected Into the Striatum and Substantia Nigra of Patients With Parkinson's Disease | Parkinson Disease | Biological: ISC-hpNSC | Cyto Therapeutics Pty Limited | NULL | Active, not recruiting | 30 Years | 70 Years | All | 12 | Phase 1 | Australia |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 261 | NCT02615873 (ClinicalTrials.gov) | July 2016 | 23/11/2015 | A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004 | An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004 | Parkinson's Disease | Drug: Accordion Pill™ Carbidopa/Levodopa | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | 100 Years | All | 460 | Phase 3 | United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom |
| 262 | EUCTR2015-004344-19-FR (EUCTR) | 29/06/2016 | 20/04/2016 | An international trial of deferiprone in patients with parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | Parkinson’s disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | ApoPharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | United States;France;Canada;Germany;Italy;United Kingdom | |||
| 263 | EUCTR2015-005626-19-CZ (EUCTR) | 23/06/2016 | 14/04/2016 | A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodes | A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 20.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Czech Republic;Canada;Poland;Spain | ||
| 264 | EUCTR2015-003512-20-PL (EUCTR) | 22/06/2016 | 01/04/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 265 | EUCTR2015-004912-39-DE (EUCTR) | 14/06/2016 | 11/02/2016 | A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THEEFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | France;United States;Spain;Germany;Japan;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 266 | EUCTR2015-005626-19-ES (EUCTR) | 13/06/2016 | 20/04/2016 | A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodes | A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, a wholly owned subsidiary of Acorda | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Czech Republic;Canada;Poland;Spain | ||
| 267 | EUCTR2015-003512-20-IT (EUCTR) | 08/06/2016 | 05/11/2020 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill¿ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson¿s Disease Patients - Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 MedDRA version: 20.0;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy | ||
| 268 | JPRN-UMIN000022529 | 2016/06/01 | 01/06/2016 | Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease | Parkinson's disease | 8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium10 Capsules(once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg) Washout 6days 8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap 8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap Washout 6days 8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium10 Capsules(once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg) | Utano National Hospital, National Hospital Organization | NULL | Complete: follow-up complete | 20years-old | 85years-old | Male and Female | 8 | Phase 3 | Japan | |
| 269 | NCT02807675 (ClinicalTrials.gov) | June 2016 | 17/6/2016 | A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder) | A Phase 1 Study of the Safety and Tolerability of a Single Dose Administration of CVT- 301 (Levodopa Inhalation Powder) When Administered for Early Morning OFF Symptoms in Patients With Parkinson's Disease | Parkinson's Disease | Drug: CVT-301, LIP;Other: Placebo | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 36 | Phase 1 | United States |
| 270 | NCT02785978 (ClinicalTrials.gov) | June 2016 | 11/5/2016 | Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers | Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers | Parkinson Disease;Healthy Volunteers | Drug: Levodopa acute challenge;Other: Controlled environment tests (series of tasks of everyday life);Other: Standardized scales: MDS-UPDRS (Part II to IV) and RDRS;Device: ActiMyo recording;Other: Diary completion | Institut de Myologie, France | NULL | Completed | 18 Years | N/A | All | 30 | N/A | France |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 271 | JPRN-UMIN000009062 | 2016/05/30 | 09/10/2012 | An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease | Parkinson's disease | Take oral inosine 500-3000mg/day to achieve a serum UA level between 6.0-8.0 mg/dL | Dept. of Clinical pharmacology and Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Phase 1 | Japan | |
| 272 | EUCTR2015-003512-20-ES (EUCTR) | 18/05/2016 | 18/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill? Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson?s Disease Patients | Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 273 | EUCTR2016-000637-43-GB (EUCTR) | 12/05/2016 | 04/03/2016 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunovion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;France;Canada;Spain;Austria;Germany;Italy;United Kingdom | ||
| 274 | EUCTR2016-000636-18-GB (EUCTR) | 12/05/2016 | 04/03/2016 | Phase 3, placebo controlled study to examine the efficacy, safety and tolerability of APL-130277 in patients with Parkinson's disease. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 19.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Sunuvion Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 3 | United States;Canada;United Kingdom | |||
| 275 | JPRN-UMIN000022023 | 2016/05/10 | 10/05/2016 | A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora- | Parkinson diseaseChronic constipation | Study drug group: A 12-week administration of lubiprostone 24 microgrum (adjustable) twice daily after switching from magnesium oxide Control group: Continuous administration of magnesium oxide at the same dosage regimen as before the enrollmen | Dokkyo Medical University | NULL | Complete: follow-up complete | 20years-old | 90years-old | Male and Female | 64 | Not selected | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 276 | JPRN-UMIN000022022 | 2016/05/10 | 10/05/2016 | A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease | A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease - A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease | Parkinson diseaseChronic constipation | Study drug group: A 12-week administration of lubiprostone 24 microrgrum (adjustable) twice daily after switching from magnesium oxide Control group: Continuous administration of magnesium oxide at the same dosage regimen as before the enrollment | Dokkyo Medical University | NULL | Complete: follow-up complete | 20years-old | 90years-old | Male and Female | 64 | Not selected | Japan |
| 277 | EUCTR2015-003512-20-HU (EUCTR) | 09/05/2016 | 02/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 278 | JPRN-UMIN000022187 | 2016/05/06 | 06/05/2016 | Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease | Parkinson's disease | PD group, 200 mg caffeine administration, qd, 1 day Control group, 200 mg caffeine administration, qd, 1 day | Department of Neurology, Juntendo University | NULL | Complete: follow-up complete | 40years-old | 60years-old | Male and Female | 20 | Not applicable | Japan | |
| 279 | NCT02762591 (ClinicalTrials.gov) | May 3, 2016 | 3/5/2016 | Expanded Access of Pimavanserin for Patients With PD Psychosis | Expanded Access Program of Pimavanserin in Patients With Parkinson's Disease Psychosis | Parkinson's Disease Psychosis | Drug: Pimavanserin tartrate | ACADIA Pharmaceuticals Inc. | NULL | Approved for marketing | 40 Years | N/A | All | N/A | NULL | |
| 280 | NCT02728947 (ClinicalTrials.gov) | May 2016 | 31/3/2016 | Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease | A Single Group and Open-label Study to Evaluate Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease | Parkinson's Disease | Drug: ROTIGOTINE | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 99 Years | Both | 28 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 281 | EUCTR2015-003512-20-GB (EUCTR) | 28/04/2016 | 03/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | |||
| 282 | EUCTR2015-004507-23-DE (EUCTR) | 25/04/2016 | 13/01/2016 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 283 | EUCTR2015-003512-20-SK (EUCTR) | 22/04/2016 | 04/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | |||
| 284 | EUCTR2014-005630-60-AT (EUCTR) | 12/04/2016 | 04/12/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Austria;Germany | ||
| 285 | NCT02764125 (ClinicalTrials.gov) | April 8, 2016 | 13/1/2016 | Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC) | Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off | Parkinson's Disease | Drug: Stalevo;Drug: levodopa MR | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | All | 84 | Phase 2 | Finland;Germany;Hungary;Latvia |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 286 | EUCTR2015-005067-17-CZ (EUCTR) | 01/04/2016 | 25/01/2016 | A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson’s Disease Patients with OFF episodes | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™) | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 345 | Phase 3 | United States;Czech Republic;Canada;Poland;Spain | ||
| 287 | NCT02719496 (ClinicalTrials.gov) | April 2016 | 15/3/2016 | Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease | Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease | Gastrointestinal Disorders in Parkinson's Disease | Drug: IBEROGAST | Nantes University Hospital | NULL | Completed | 30 Years | 80 Years | All | 45 | Phase 2 | France |
| 288 | NCT02775591 (ClinicalTrials.gov) | April 2016 | 9/5/2016 | Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms | Effect of Short-term Motilitone Therapy on Health-related Quality of Life in Parkinson's Disease Patients With Gastrointestinal Symptoms: a Multicenter, Double-blind Randomized, Placebo-controlled Trial | Parkinson Disease;Dyspepsia | Drug: DA-9701;Drug: DA-9701 placebo | Seoul National University Hospital | Samsung Medical Center;Korea University Guro Hospital;Hanyang University;Seoul Veterans Hospital;SMG-SNU Boramae Medical Center | Completed | 50 Years | 80 Years | All | 147 | Phase 4 | Korea, Republic of |
| 289 | EUCTR2015-004344-19-GB (EUCTR) | 31/03/2016 | 16/02/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Canada;Germany;United Kingdom | ||
| 290 | JPRN-jRCTs061180060 | 22/03/2016 | 18/03/2019 | Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease | Parkinson's disease;D010300 | Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years or placebo (500mg/CP) | Nagai Masahiro | NULL | Recruiting | >= 20age old | Not applicable | Both | 100 | Phase 2 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 291 | NCT02787590 (ClinicalTrials.gov) | March 21, 2016 | 26/5/2016 | Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease | Simvastatin as a Neuroprotective Treatment for Parkinson's Disease: a Double-blind, Randomised, Placebo Controlled Futility Study in Patients of Moderate Severity. | Parkinson Disease | Drug: Simvastatin;Drug: Matched Placebo (for Simvastatin) | University Hospital Plymouth NHS Trust | University of Plymouth | Active, not recruiting | 40 Years | 90 Years | All | 235 | Phase 2 | United Kingdom |
| 292 | EUCTR2015-004507-23-LV (EUCTR) | 15/03/2016 | 13/01/2016 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson's disease and end-of-dose wearing-off. - COMPOC | Parkinson's disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Finland;Germany;Latvia | ||
| 293 | EUCTR2015-005067-17-ES (EUCTR) | 14/03/2016 | 17/02/2016 | A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson?s Disease Patients with OFF episodes | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson?s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD?) | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, a wholly owned subsidiary of Acorda Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | United States;Czech Republic;Canada;Poland;Spain | ||
| 294 | NCT02687542 (ClinicalTrials.gov) | March 3, 2016 | 29/1/2016 | Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | Parkinson Disease | Drug: Placebo;Drug: PF-06649751 low dose (1 mg QD);Drug: PF-06649751 middle dose 1 (3 mg QD);Drug: PF-06649751 middle dose 2 (7 mg QD);Drug: PF-06649751 high dose (15 mg QD) | Pfizer | NULL | Terminated | 40 Years | 85 Years | All | 108 | Phase 2 | United States;Canada;France;Germany;Japan;Spain |
| 295 | JPRN-UMIN000021236 | 2016/03/01 | 01/03/2016 | Investigation in effect of aroma therapy using magnetoencepharography | Normal volunteer, Epilepsy patients, Parkinson disease patients | aroma 1 Trans-nasal administration of lavender essence Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness. aroma 2 Trans-nasal administration of grapefruit essence Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness. fragrant Trans-nasal administration of fragrant Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness. | Osaka University Graduate School of Medicine Department of Neurosurgery | NULL | Complete: follow-up continuing | 20years-old | 80years-old | Male and Female | 10 | Phase 1 | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 296 | NCT02994719 (ClinicalTrials.gov) | March 1, 2016 | 21/12/2015 | Gait Analysis in Neurological Disease | Gait Pattern Analysis in Neurological Disease | Parkinson's Disease;Parkinsonian Disorders;Atypical Parkinson Disease;Progressive Supranuclear Palsy;Multiple System Atrophy;Corticobasal Degeneration;Gait, Frontal;Huntington Disease | Drug: Anti-Parkinson medication;Device: Deep Brain Stimulation | Beth Israel Deaconess Medical Center | NULL | Active, not recruiting | 18 Years | 85 Years | All | 120 | United States | |
| 297 | NCT02605434 (ClinicalTrials.gov) | March 2016 | 5/11/2015 | A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients | Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients | Parkinson's Disease | Drug: Accordion Pill™ Carbidopa/Levodopa;Drug: Sinemet®;Drug: Placebo -AP-CD/LD;Drug: Placebo- Sinemet | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | N/A | All | 420 | Phase 3 | United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom;Hungary |
| 298 | NCT04569656 (ClinicalTrials.gov) | February 2, 2016 | 24/9/2020 | Treatment of Chronic Constipation in Parkinson's Disease | Pilot Study for the Evaluation of the Parameters of Activity of a Preparation of PHGG and Sodium Hyaluronate in Chronic Constipation in Patients With Parkinson's Disease | Parkinson Disease | Drug: hydrolyzed guar gum | IRCCS San Raffaele | NULL | Completed | 18 Years | N/A | All | 34 | Phase 2 | Italy |
| 299 | NCT02618941 (ClinicalTrials.gov) | February 2, 2016 | 25/11/2015 | Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA) | Phase IB Follow-up, Controlled, Parallel Group, Single-center Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological and Clinical Activity in Patients Who Have Participated in the AFF008 Program | Parkinson's Disease | Biological: AFFITOPE® PD01A | Affiris AG | NULL | Completed | 40 Years | 68 Years | All | 26 | Phase 1 | Austria |
| 300 | JPRN-UMIN000020527 | 2016/02/01 | 01/02/2016 | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease | Parkinson's disease | Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years Lactose as a placebo for 2 years | Ehime University Graduate School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 100 | Phase 2 | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 301 | JPRN-UMIN000020288 | 2016/02/01 | 28/12/2015 | Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. | Parkinson's disease | In this research, the duration of evaluation will be 12 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline. | Juntendo University Shizuoka Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | |
| 302 | NCT02683629 (ClinicalTrials.gov) | February 2016 | 8/2/2016 | Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease | A Phase IIb, Randomised, Double-blind, Placebo-controlled, Dose-range Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease | Parkinson's Disease | Biological: NTCELL Implantation;Other: Sham Surgery | Living Cell Technologies | Statistecol Consultants Limited | Completed | 40 Years | 65 Years | All | 18 | Phase 2 | New Zealand |
| 303 | NCT02641054 (ClinicalTrials.gov) | February 2016 | 7/12/2015 | Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease | Double-Blind Randomized Placebo-Controlled Cross-Over Phase IIa Trial to Evaluate Efficacy of CVXL-0107 on Parkinson-Related Symptoms and Levodopa-Induced Dyskinesia in Advanced Parkinson's Disease Patients Using a Levodopa Challenge Test | Idiopathic Parkinson Disease | Drug: CVXL-0107;Drug: Placebo;Drug: Levodopa | CleveXel Pharma | NULL | Completed | 40 Years | 75 Years | All | 21 | Phase 2 | France |
| 304 | EUCTR2015-001786-10-GB (EUCTR) | 18/01/2016 | 23/11/2015 | A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease. | A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: EPI-589 Product Code: EPI-589 Other descriptive name: (R)-troloxamide quinone | BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Germany;United Kingdom | ||
| 305 | NCT03258294 (ClinicalTrials.gov) | January 13, 2016 | 20/8/2017 | Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease | Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial | Parkinson's Disease | Drug: Melatonin(Circadin®);Drug: Placebo Oral Tablet | KIMJisun | Kuhnil Pharmaceutical Co., Ltd. | Enrolling by invitation | 55 Years | N/A | All | 82 | Phase 4 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 306 | ChiCTR-CPC-15007223 | 2016-01-01 | 2015-09-22 | Characteristics andAffecting Factors Amalysis of Sleep Disorder in Parkinsons Disease | Characteristics andAffecting Factors Amalysis of Sleep Disorder in Parkinsons Disease | Parkinsons Disease; Sleep Disorder | The treatment group; The control group:Rotigotine patch; | Department of Neurology, Changzheng Hospital, Second Military Medical University | NULL | Pending | Both | The treatment group; The control group:100; | China | |||
| 307 | NCT02768077 (ClinicalTrials.gov) | January 2016 | 9/5/2016 | Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease | Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial | Parkinson's Disease | Drug: Melatonin(Circadin®);Drug: Placebo | Kuhnil Pharmaceutical Co., Ltd. | NULL | Enrolling by invitation | 55 Years | N/A | Both | 100 | Phase 4 | NULL |
| 308 | NCT02649608 (ClinicalTrials.gov) | January 2016 | 6/1/2016 | An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients | Interventional, Open-label, Exploratory Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AE04621 and the Active Metabolite Lu AA40326 After Ascending Oral Doses of Lu AE04621 to Patients With Parkinson's Disease | Parkinson Disease | Drug: 0.04 mg Lu AE04621;Drug: 0.08 mg Lu AE04621;Drug: 0.2 mg Lu AE04621;Drug: 0.4 mg Lu AE04621;Drug: 0.6 mg Lu AE04621;Drug: 0.8 mg Lu AE04621;Drug: 1.0 mg Lu AE04621;Drug: 1.2 mg Lu AE04621 | H. Lundbeck A/S | NULL | Completed | 45 Years | 75 Years | All | 15 | Phase 1 | United States |
| 309 | EUCTR2014-002600-24-AT (EUCTR) | 30/12/2015 | 25/09/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 310 | JPRN-JapicCTI-153057 | 14/12/2015 | 02/11/2015 | ME2125 Phase III (ME2125-4) | A Phase III, Long-Term Treatment Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon | Parkinson's disease | Intervention name : ME2125 (safinamide mesilate) INN of the intervention : safinamide Dosage And administration of the intervention : Orally administer a dose of 2 tablets once a daily in morning. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Orally administer a dose of 2 tablets once a daily in morning. | Meiji Seika Pharma Co., Ltd. | NULL | complete | 30 | BOTH | 200 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 311 | EUCTR2014-002600-24-IT (EUCTR) | 11/12/2015 | 16/02/2018 | Safinamide versus placebo in patients with Parkinson's disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Safinamide Product Code: na INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO Trade Name: Xadago INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO | ZAMBON SPA | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 312 | EUCTR2014-005630-60-ES (EUCTR) | 11/12/2015 | 05/10/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) - TOZ-PD | Parkinson´s Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Germany | ||
| 313 | EUCTR2014-002600-24-SE (EUCTR) | 03/12/2015 | 30/07/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 314 | NCT02702102 (ClinicalTrials.gov) | December 2015 | 3/3/2016 | Imaging Inflammation in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies | Imaging Inflammation in Patients With Diffuse Lewy Body Disease | Diffuse Lewy Body Disease;Dementia With Lewy Bodies;Parkinson's Disease Dementia | Drug: 11C-PBR28 | William Charles Kreisl | National Institute on Aging (NIA) | Completed | 60 Years | N/A | All | 5 | Phase 2 | United States |
| 315 | NCT02616120 (ClinicalTrials.gov) | December 2015 | 20/11/2015 | Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's Disease | Efficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease Patients | Parkinson's Disease | Drug: SQJZ herbal mixtures;Drug: Placebo | Dongzhimen Hospital, Beijing | NULL | Recruiting | 18 Years | 80 Years | All | 240 | Phase 2 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 316 | NCT02536976 (ClinicalTrials.gov) | December 2015 | 28/8/2015 | Mirabegron in Parkinson Disease and Impaired Cognition | A Clinical Trial of Mirabegron for Overactive Bladder Symptoms in Patients With Parkinson Disease and Impaired Cognition | Parkinson Disease;Overactive Bladder;Impaired Cognition | Drug: mirabegron;Drug: Placebo | HealthPartners Institute | NULL | Completed | 25 Years | 80 Years | All | 7 | Phase 4 | United States |
| 317 | JPRN-JapicCTI-153056 | 24/11/2015 | 02/11/2015 | ME2125 Phase II/III (ME2125-3) | A Phase II/III, Double-Blind, Placebo-Controlled Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon | Parkinson's disease | Intervention name : ME2125 (safinamide mesilate) INN of the intervention : safinamide Dosage And administration of the intervention : Orally administer a dose of 2 tablets once a daily in morning. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Orally administer a dose of 2 tablets once a daily in morning. | Meiji Seika Pharma Co., Ltd. | NULL | complete | 30 | BOTH | 410 | Phase 2;Phase 3 | Japan | |
| 318 | EUCTR2015-002631-17-ES (EUCTR) | 19/11/2015 | 03/11/2015 | A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patients | An intra-subject, randomized, double blind, crossover study comparing immediate-release oral LD (IR-LD) and L-dopa/carbidopa intestinal gel (LCIG) over cognition and mood in non-demented advanced Parkinson?s disease (PD) patients | Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Institut de Recerca del Hospital de la Santa Creu i Sant Pau | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 4 | Spain | |||
| 319 | EUCTR2014-002600-24-ES (EUCTR) | 19/11/2015 | 05/10/2015 | Safinamide versus placebo in patients with Parkinson?s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON?S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 320 | EUCTR2015-000148-40-GB (EUCTR) | 09/11/2015 | 16/09/2015 | A trial comparing simvastatin to placebo as a neuronal protective treatment for Parkinson's disease. | Simvastatin as a neuroprotective treatment for Parkinson's disease: a double-blind, randomised, placebo controlled futility study in patients of moderate severity. - Simvastatin as a neuroprotective treatment for moderate PD (PD STAT) | Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Simvastatin INN or Proposed INN: Simvastatin | Plymouth Hospitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 3 | United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 321 | JPRN-jRCTs041180070 | 04/11/2015 | 07/03/2019 | Trerief Impact in PD PET Study | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS | Parkinson's disease Parkinson's disease;D010300 | [1] Zonisamide treatment group Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. [2] Zonisamide non-treatment group Only levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Ouchi Yasuomi | NULL | Not Recruiting | Not applicable | < 80age old | Both | 20 | N/A | Japan |
| 322 | EUCTR2014-002600-24-GB (EUCTR) | 03/11/2015 | 28/07/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Switzerland;Italy;United Kingdom;Sweden | ||
| 323 | NCT02758730 (ClinicalTrials.gov) | November 2015 | 26/4/2016 | Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A in PD-GBA Patients | A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Single-center Phase I Pilot Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A, a New Vaccine Against Alpha-synuclein, in Patients With PD-GBA | Parkinson's Disease | Biological: AFFITOPE® PD01A + Adjuvant;Biological: Adjuvant without active component | Affiris AG | University Hospital Tuebingen | Withdrawn | 40 Years | 80 Years | Both | 0 | Phase 1 | Germany |
| 324 | NCT02632279 (ClinicalTrials.gov) | November 2015 | 26/11/2015 | Tryptophan Depletion in PD Patients Treated With STN DBS | Tryptophan Depletion in Parkinson's Disease Patients Treated With Deep Brain Stimulation of the Subthalamic Nucleus: Effects on Mood and Motor Functions | Parkinson's Disease | Dietary Supplement: Tryptophan (TRP) depletion;Dietary Supplement: Placebo;Device: Stimulator ON;Device: Stimulator OFF | Maastricht University Medical Center | Netherlands Brain Foundation | Terminated | N/A | N/A | All | 7 | N/A | Netherlands |
| 325 | NCT02271503 (ClinicalTrials.gov) | November 2015 | 13/10/2014 | A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease | A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease | Parkinson's Disease | Drug: CD-LD IR;Drug: IPX203 180 mg;Drug: IPX203 270 mg;Drug: Rytary 195 mg;Drug: Rytary 145 mg | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 26 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 326 | EUCTR2014-005630-60-DE (EUCTR) | 29/10/2015 | 07/07/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Austria;Germany | ||
| 327 | EUCTR2015-003045-26-SE (EUCTR) | 23/10/2015 | 15/09/2015 | Study of Dopamine Transporters (signal substance in central nervous system)in patients with early signs of Parkinson´s disease. | [18F] FE-PE2I PET/CT study of Dopamine Transporters in Early Parkinsonian disease. | Patients with newly clinically diagnosed untreated idiopathic parkinsonism MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [18F]FE-PE2I INN or Proposed INN: [18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4'-methylphenyl)nortropane Trade Name: DaTSCAN INN or Proposed INN: IOFLUPANE (123I) Product Name: 15O H2O INN or Proposed INN: [15O]H2O | Umeå University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | Sweden | ||
| 328 | JPRN-UMIN000019524 | 2015/10/01 | 28/10/2015 | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - Trerief Impact in PD PET Study (TIPPS) | Parkinson's Disease | Zonisamide treatment group: Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. Zonisamide non-treatment group: Only Levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | Not applicable | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 329 | EUCTR2014-005630-60-CZ (EUCTR) | 23/09/2015 | 10/07/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc. (a wholly owned subsidiary of Acorda Therapeutics Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Austria;Germany | ||
| 330 | NCT02542696 (ClinicalTrials.gov) | August 31, 2015 | 3/9/2015 | Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson Disease | Drug: APL-130277 | Sunovion | NULL | Recruiting | 18 Years | N/A | All | 226 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 331 | EUCTR2015-000373-13-DE (EUCTR) | 18/08/2015 | 18/05/2015 | A study to examine the effectiveness and safety of a new drug for involuntary muscle movements in patients with Parkinson’s disease | Phase 2, multicenter, randomized, double-blind, placebo-controlled, four-period cross-over, dose-range finding study to evaluate the safety, tolerability and efficacy of Eltoprazine in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease. | Parkinson’s disease levodopa induced dyskinesia (PD-LID) MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE | Amarantus BioScience Holdings, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Germany;Sweden | ||
| 332 | NCT02599753 (ClinicalTrials.gov) | August 2015 | 1/11/2015 | Investigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease Patients | Investigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease Patients With Neuropsychiatric Disorders by Multimodal Neuroimaging | Parkinson's Disease | Drug: 18-FDTBZ | Chang Gung Memorial Hospital | NULL | Completed | 20 Years | 80 Years | All | 35 | Phase 2 | Taiwan |
| 333 | NCT02337751 (ClinicalTrials.gov) | July 10, 2015 | 9/1/2015 | A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants | A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa | Parkinson's Disease | Drug: TVP-1012 1mg | Takeda | NULL | Completed | 30 Years | 79 Years | All | 198 | Phase 3 | Japan |
| 334 | NCT02453386 (ClinicalTrials.gov) | July 2015 | 21/5/2015 | Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off (TOZ-PD) | Idiopathic Parkinson's Disease | Drug: tozadenant;Drug: placebo | Biotie Therapies Inc. | NULL | Terminated | 30 Years | 80 Years | All | 449 | Phase 3 | United States;Austria;Canada;Czechia;Germany;Italy;Spain;Czech Republic |
| 335 | EUCTR2014-003738-24-AT (EUCTR) | 26/06/2015 | 01/04/2015 | A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease | ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 17.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | Germany;Spain;Austria;United States | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 336 | NCT02469090 (ClinicalTrials.gov) | June 18, 2015 | 9/6/2015 | Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson Disease, Off Episodes | Drug: APL-130277;Drug: Placebo | Sunovion | NULL | Completed | 18 Years | N/A | All | 141 | Phase 3 | United States;Canada;United Kingdom |
| 337 | NCT02769793 (ClinicalTrials.gov) | June 2015 | 9/5/2016 | Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON | Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in Parkinson's Disease Patients With Delayed ON: a Multicenter Randomized Open-label Cross-over Trial | Parkinson Disease | Drug: Levodopa dispersible;Drug: Levodopa | Seoul National University Hospital | SMG-SNU Boramae Medical Center;Samsung Medical Center | Unknown status | 31 Years | 80 Years | All | 40 | Phase 4 | Korea, Republic of |
| 338 | EUCTR2014-005422-35-GB (EUCTR) | 28/05/2015 | 02/04/2015 | The role of Buspirone in attenuating involuntary movements (Dyskinesias) in patients with Parkinson's disease. | THE ROLE OF BUSPIRONE IN ATTENUATING LEVODOPA-INDUCED DYSKINESIAS IN PATIENTS WITH PARKINSON'S DISEASE: A CLINICAL AND POSITRON EMISSION TOMOGRAPHY STUDY WITH 11C-PHNO. - The role of buspirone in LIDs in patients with Parkinson’s disease. | Levodopa induced dyskinesias within Parkinson's disease. MedDRA version: 17.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Imperial College London-Imperial College Healthcare NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 4 | United Kingdom | |||
| 339 | JPRN-jRCTs061180028 | 11/05/2015 | 26/02/2019 | Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine | Parkinson's disease;D010300 | The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. | Ando Rina | NULL | Complete | 20 years old | None | Both | 50 | Phase 2 | Japan |
| 340 | EUCTR2014-003799-22-AT (EUCTR) | 08/05/2015 | 12/01/2015 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 341 | EUCTR2010-024424-26-SK (EUCTR) | 05/05/2015 | 28/04/2015 | Clinical study for the evaluation of the safety and efficacy of masitinib in patients suffering from parkinson's disease | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo on cognitive impairment associated with Parkinson's disease | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | France;United States;Hungary;Czech Republic;Slovakia;Spain;Romania;Bulgaria;South Africa;Germany | |||
| 342 | NCT02448914 (ClinicalTrials.gov) | May 2015 | 12/5/2015 | A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients | A Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s Disease | Parkinson's Disease | Drug: TRIGEL;Drug: Duodopa | LobSor Pharmaceuticals AB | TFS Trial Form Support | Completed | 30 Years | N/A | All | 11 | Phase 1 | Sweden |
| 343 | NCT02439125 (ClinicalTrials.gov) | May 2015 | 13/4/2015 | A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients | Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, 4-way Crossover, Dose-finding Study, of Eltoprazine Safety, Tolerability and Efficacy in the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson's Disease | Parkinson's Disease;Dyskinesia | Drug: Eltoprazine HCl;Drug: Placebo | Amarantus BioScience Holdings, Inc. | NULL | Active, not recruiting | 30 Years | 85 Years | Both | 60 | Phase 2 | United States |
| 344 | EUCTR2014-003738-24-DE (EUCTR) | 23/04/2015 | 21/01/2015 | A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease | ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | United States;Spain;Austria;Germany | ||
| 345 | EUCTR2014-003799-22-DE (EUCTR) | 22/04/2015 | 04/12/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 346 | JPRN-JapicCTI-152870 | 11/4/2015 | 14/04/2015 | A parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPA | A phase III parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPA | Parkinson's disease | Intervention name : HP-3000 (ropinirole hydrochloride patch) Dosage And administration of the intervention : Transdermal, once daily Control intervention name : HP-3000 placebo Dosage And administration of the control intervention : Transdermal, once daily Control intervention name : Ropinirole hydrochloride extended-release tablet Dosage And administration of the control intervention : Oral, once daily Control intervention name : Ropinirole hydrochloride extended-release tablet placebo Dosage And administration of the control intervention : Oral, once daily | Hisamitsu Pharmaceutical Co.,Inc. | NULL | 20 | 79 | BOTH | Phase 3 | NULL | ||
| 347 | JPRN-UMIN000017036 | 2015/04/03 | 03/04/2015 | Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia. | autonomic failure such as Parkinson's disease | blood test of Leptin and Ghrelin blood test of Leptin and Ghrelin | Nagoya University Graduate School of Medicine | NULL | Complete: follow-up complete | 40years-old | Not applicable | Male and Female | 50 | Not applicable | Japan | |
| 348 | EUCTR2014-003738-24-ES (EUCTR) | 24/03/2015 | 16/02/2015 | A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease | ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | United States;Spain;Austria;Germany | ||
| 349 | EUCTR2014-003799-22-BE (EUCTR) | 16/03/2015 | 16/12/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 365 | Phase 3 | Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | ||
| 350 | JPRN-UMIN000016664 | 2015/03/01 | 01/03/2015 | Effect of nicotine patch in Cognitive function improvement in Parkinson's disease | Parkinson's disease | nicotine patch | Department of Clinical Pharmacology and Neurology Ehime University graduated School of Medicine | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 20 | Not selected | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 351 | NCT02352363 (ClinicalTrials.gov) | March 2015 | 26/1/2015 | Randomized Safety Study of CVT-301 Compared to an Observational Control Group | A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control | Idiopathic Parkinson's Disease | Drug: CVT-301;Other: Observational cohort | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 408 | Phase 3 | United States;Austria;Belgium;Czechia;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Serbia;Spain;United Kingdom;Czech Republic;Italy |
| 352 | NCT02242487 (ClinicalTrials.gov) | March 2015 | 15/9/2014 | Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes | A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) | Idiopathic Parkinson's Disease | Drug: CVT-301 | Acorda Therapeutics | NULL | Completed | 30 Years | 86 Years | All | 325 | Phase 3 | United States;Canada;Czechia;Poland;Spain;Czech Republic |
| 353 | EUCTR2014-003799-22-CZ (EUCTR) | 26/02/2015 | 26/11/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | ||
| 354 | JPRN-UMIN000016485 | 2015/02/25 | 09/02/2015 | Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome | Healthy subjects, Parkinson's disease patients and Parkinson's syndrome patients | Intravenous injection of 18F-fluoro-dopa and 11C-raclopride PET imaging | Institute of Biomedical Research and Innovation | NULL | Complete: follow-up complete | 35years-old | Not applicable | Male and Female | 20 | Not selected | Japan | |
| 355 | EUCTR2014-003799-22-HU (EUCTR) | 11/02/2015 | 20/11/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 365 | Phase 3 | Serbia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Poland;Romania;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 356 | NCT02337725 (ClinicalTrials.gov) | February 7, 2015 | 9/1/2015 | A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa | Parkinson's Disease | Drug: TVP-1012;Drug: Placebo | Takeda | NULL | Completed | 30 Years | 80 Years | All | 244 | Phase 3 | Japan |
| 357 | NCT02337764 (ClinicalTrials.gov) | February 3, 2015 | 9/1/2015 | A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants | A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients | Parkinson's Disease | Drug: TVP-1012 1mg | Takeda | NULL | Completed | 30 Years | 79 Years | All | 222 | Phase 3 | Japan |
| 358 | EUCTR2014-003799-22-ES (EUCTR) | 02/02/2015 | 16/12/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson?s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson?s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 365 | Phase 3 | Serbia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | ||
| 359 | NCT02339064 (ClinicalTrials.gov) | February 2015 | 31/3/2014 | Infusion of Apomorphine: Long-term Safety Study | A Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available Therapy | Idiopathic Parkinson's Disease | Drug: apomorphine infusion | US WorldMeds LLC | NULL | Active, not recruiting | 30 Years | N/A | All | 99 | Phase 3 | United States |
| 360 | NCT02409823 (ClinicalTrials.gov) | February 2015 | 1/4/2015 | Clinical Registry of Patients Under Treatment With Atypical Antipsychotics | Clinical Registry of Patients Under Treatment With Atypical Antipsychotics | Schizophrenia;Major Depressive Disorder;Bipolar Depressive Disorder;Parkinson's Disease With Hallucinations | Drug: Atypical Antipsychotics | Pontifical Catholic University of Argentina | NULL | Completed | 18 Years | N/A | Both | 665 | N/A | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 361 | NCT02337738 (ClinicalTrials.gov) | January 27, 2015 | 9/1/2015 | A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing Off | Parkinson's Disease | Drug: TVP-1012 1mg;Drug: TVP-1012 0.5mg;Drug: Placebo | Takeda | NULL | Completed | 30 Years | 79 Years | All | 404 | Phase 2;Phase 3 | Japan |
| 362 | JPRN-JapicCTI-152762 | 27/1/2015 | A long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Patients | A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients | Parkinson's disease | Intervention name : TVP-1012 (1 mg/day) with levodopa Dosage And administration of the intervention : TVP-1012 (1 mg/day) once daily, before or after breakfast. A levodopa combination drug will be concomitantly administered in principle without change in the dose regimen throughout the study period from the start of the screening period. Control intervention name : null | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | 30 | 79 | BOTH | 215 | Phase 3 | NULL | ||
| 363 | EUCTR2014-003799-22-GB (EUCTR) | 15/01/2015 | 21/11/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 365 | Phase 3 | Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | |||
| 364 | NCT02406105 (ClinicalTrials.gov) | January 2015 | 22/2/2015 | An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease | An Evaluation of Effectiveness and Toxicity of CyberKnife Based Functional Radiosurgery for Parkinson Disease Patients Suffering From Tremor and Its Implementation in Poland | Parkinson Disease | Radiation: Radiosurgical thalamotomy;Drug: CyberKnife | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology | NULL | Recruiting | 18 Years | N/A | Both | 27 | Phase 2 | Poland |
| 365 | NCT02763137 (ClinicalTrials.gov) | January 2015 | 26/4/2016 | Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients | A Phase IIa Study to Assess the Safety, Tolerability, Plasma Pharmacokinetics and Efficacy of Intermittent Oral Administration of Standard Levodopa/Carbidopa vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Patients With Advanced Parkinson's Disease Who Suffer Motor Fluctuations | Parkinson Disease | Drug: Standard LD/CD;Drug: Semi continuous intra-oral administration of LD/CD | IRCCS San Raffaele | SynAgile Corporation | Completed | 35 Years | 75 Years | Both | 18 | Phase 2 | Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 366 | EUCTR2014-004501-32-NL (EUCTR) | 11/12/2014 | 03/12/2014 | Treatment in Advanced Parkinson's disease: a cost-effectiveness analysis of two different treatments | Infusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's diseasecomparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treetment Deep BrainStimulation; - INVEST (INfusion VErsus STimulation) | Patients with advanced PD who's motor symptoms — severe responsefluctuations, dyskinesias, painful dystonia and / or bradykinesia —cannot be controlled despite optimal oral pharmacological therapy.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, levodopa 20 mg/ml + carbidopa 5 mg/ml, intestinal gel | Academic Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 367 | JPRN-JapicCTI-142748 | 11/12/2014 | 16/12/2014 | Long-term study of HP-3000 in patients with Parkinson's disease | A phase III long-term study of HP-3000 in patients with Parkinson's disease | Parkinson's disease | Intervention name : HP-3000(ropinirole hydrochloride patch) Dosage And administration of the intervention : Transdermal, once daily | Hisamitsu Pharmaceutical Co.,Inc. | NULL | 20 | 79 | BOTH | Phase 3 | NULL | ||
| 368 | NCT02267434 (ClinicalTrials.gov) | December 2014 | 4/9/2014 | Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's Disease | A Randomized, Placebo-controlled, Parallel Group, Patient-blinded, Multi-center, Phase I Pilot Study to Assess Tolerability and Safety of Two Doses of AFFITOPE® PD03A Formulated With Adjuvant to Patients With Early Parkinson's Disease | Parkinson Disease;Neurodegenerative Diseases | Biological: Low dose AFFITOPE® PD03A + Adjuvant;Biological: High dose AFFITOPE® PD03A + Adjuvant;Biological: Adjuvant without active component | Affiris AG | PROSENEX AmbulatoriumbetriebsGMBH;Medical University Innsbruck;Forschungszentrum Juelich | Completed | 45 Years | 70 Years | Both | 36 | Phase 1 | Austria |
| 369 | EUCTR2014-001132-10-FR (EUCTR) | 18/11/2014 | 18/06/2015 | A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson’s Disease Patients with Abnormal Involuntary Movements caused by Levodopa | A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesias | Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesias MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE | Osmotica Pharmaceutical Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | United States;France;Canada;Spain;Germany | |||
| 370 | JPRN-JapicCTI-142702 | 01/11/2014 | 12/11/2014 | A Phase 1 Study of ONO-2160/CD | A Phase 1 study on single and multiple oral dose administration of ONO-2160/CD in healthy adult male subjects and on multiple oral dose administration of ONO-2160/CD in Parkinson's disease patients | Parkinson's disease | Intervention name : ONO-2160/CD Dosage And administration of the intervention : Oral administration Control intervention name : Levodopa/carbidopa hydrate INN of the control intervention : Levodopa/carbidopa hydrate Dosage And administration of the control intervention : Oral administration | ONO PHARMACEUTICAL CO.,LTD. | NULL | BOTH | 34 | Phase 1 | NULL | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 371 | NCT02240030 (ClinicalTrials.gov) | November 2014 | 11/9/2014 | Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™) | Idiopathic Parkinson's Disease | Drug: CVT-301 Low Dose;Drug: CVT-301 High Dose;Other: Placebo | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 351 | Phase 3 | United States;Canada;Czechia;Poland;Spain;Czech Republic |
| 372 | NCT02281474 (ClinicalTrials.gov) | November 2014 | 27/10/2014 | Nilotinib in Cognitively Impaired Parkinson Disease Patients 001 | Open Label Dose Escalation of Nilotinib in Cognitively Impaired Parkinson Disease Patients With Elevated Cerebrospinal Fluid and Blood a-Synuclein | Parkinson's Disease;Parkinson's Disease Dementia;Diffuse Lewy Body Disease | Drug: Nilotinib | Georgetown University | NULL | Completed | 40 Years | 90 Years | Both | 12 | Phase 1 | United States |
| 373 | EUCTR2014-001131-36-ES (EUCTR) | 23/10/2014 | 03/09/2014 | A 16 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by Levodopa | A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias | Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE | Osmotica Pharmaceutical Corp. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | France;United States;Canada;Spain;Germany | ||
| 374 | EUCTR2014-001132-10-ES (EUCTR) | 23/10/2014 | 02/09/2014 | A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by Levodopa | A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias | Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE | Osmotica Pharmaceutical Corp. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | France;United States;Canada;Spain;Germany | ||
| 375 | EUCTR2014-002295-87-IT (EUCTR) | 13/10/2014 | 29/09/2014 | A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations. | A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations. | Parkinson's disease patients who suffer motor fluctuations willparticipate in the study MedDRA version: 17.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 100 mg + 25 mg compresse Product Name: SINEMET 100 mg + 25 mg compresse Product Code: NA | SynAgile Corporation | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 376 | NCT02274324 (ClinicalTrials.gov) | October 2014 | 22/10/2014 | Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease | Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's Disease | Parkinson Disease | Dietary Supplement: different diets | Sheba Medical Center | Tel Aviv University | Not yet recruiting | 40 Years | 80 Years | Both | 20 | N/A | NULL |
| 377 | NCT02274766 (ClinicalTrials.gov) | October 2014 | 22/10/2014 | Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia | ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study) | Dyskinesia;Levodopa-Induced Dyskinesia (LID);Parkinson's Disease (PD) | Drug: ADS-5102;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 77 | Phase 3 | United States;Austria;France;Germany;Spain |
| 378 | JPRN-UMIN000016893 | 2014/09/22 | 01/04/2015 | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine. | PD patients | The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. | Ehime University HospitalDept. of Clinical pharmacology and Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Phase 2 | Japan |
| 379 | NCT02225548 (ClinicalTrials.gov) | September 2014 | 22/8/2014 | Sagene 2014 - Parkinson's Disease and Erectile Dysfunction | An Open-label Trial of Oral Selegiline 5 or 10 mg and Tadalafil 2.5mg Co-administration to Male Patients With Parkinson's Disease and Moderate Erectile Dysfunction. | Parkinson's Disease;Erectile Dysfunction | Drug: Selegiline;Drug: Tadalafil | University of South Florida | NULL | Recruiting | 40 Years | 64 Years | Male | 10 | Phase 4 | United States |
| 380 | NCT02230904 (ClinicalTrials.gov) | September 2014 | 29/8/2014 | A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease | A Multicenter, Randomized, Double-blind, 2-way Cross-over Study to Compare the Adhesiveness of 2 Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine (Test product PR 2.3.1);Drug: Rotigotine (Reference product PR 2.1.1) | UCB BIOSCIENCES GmbH | Pharmaceutical Health Sciences;Bracket Global | Completed | 18 Years | N/A | All | 57 | Phase 1 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 381 | NCT02777060 (ClinicalTrials.gov) | September 2014 | 8/6/2015 | Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures | Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures | Diabetes;Cancer;Multiple Sclerosis;Arthritis;Parkinson's Disease;Cognitive Disorders;Brain Injury;Stroke | Procedure: Exergame;Procedure: Home based balance training | University of Arizona | NULL | Recruiting | 18 Years | N/A | Both | 200 | N/A | United States |
| 382 | NCT02228590 (ClinicalTrials.gov) | August 31, 2014 | 26/8/2014 | A Study to Examine APL-130277 in Patients With Parkinson's Disease | A Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: APL-130277 | Sunovion | NULL | Completed | 18 Years | 80 Years | All | 20 | Phase 2 | United States |
| 383 | NCT02153645 (ClinicalTrials.gov) | August 18, 2014 | 30/5/2014 | Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID. | A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias | Parkinson's Disease;Levodopa Induced Dyskinesias (LID) | Drug: 240mg Amantadine HCl ER tablets;Drug: Placebo tablets;Drug: 320mg Amantadine HCl ER tablets | Osmotica Pharmaceutical US LLC | NULL | Terminated | 30 Years | 85 Years | All | 87 | Phase 3 | United States;Canada;France;Germany;Spain |
| 384 | NCT02236065 (ClinicalTrials.gov) | August 2014 | 8/9/2014 | Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative Disorders | A Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative Disorders | Brain Injury;Cerebral Palsy;Amyotrophic Lateral Sclerosis;Parkinson's Disease | Procedure: Umbilical cord blood therapy;Biological: Filgrastim | MinYoung Kim, M.D. | NULL | Completed | 19 Years | 75 Years | All | 10 | N/A | Korea, Republic of |
| 385 | NCT02216188 (ClinicalTrials.gov) | August 2014 | 12/8/2014 | Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity | Phase IB Follow-up, Randomized, Controlled, Parallel Group, Patient-blinded, Single-center Study to Assess One Boost With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological + Clinical Activity in Patients Who Have Received the Vaccine Within the Study AFF008 | Parkinson's Disease | Biological: AFFITOPE® PD01A;Other: Control | Affiris AG | NULL | Completed | 40 Years | 68 Years | Both | 28 | Phase 1 | Austria |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 386 | NCT02096601 (ClinicalTrials.gov) | August 2014 | 18/3/2014 | A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients | A Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LD | Parkinson's Disease | Drug: Levodopa and carbidopa SC solution;Drug: Oral levodopa and carbidopa | NeuroDerm Ltd. | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | 80 Years | All | 16 | Phase 1;Phase 2 | United States;Israel |
| 387 | JPRN-UMIN000014709 | 2014/07/01 | 01/08/2014 | Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I | Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I - DAT PET with [C-11]PE2I in PD and related disorders | Patients of Parkinson's disease and related disorders | The dosage in the vein of [C-11]PE2I, [C-11]raclopride, and [F-18]FDG for PET/CT imaging. | Tokyo Metropolitan Institute of Gerontology | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 200 | Not selected | Japan |
| 388 | NCT02472210 (ClinicalTrials.gov) | July 2014 | 11/6/2015 | The Use of Botox in Advanced Parkinson's Patients Experiencing Pain | A Study of the Utility of Botulinum Toxin Type A for Pain in Advanced Parkinson's Disease Double Blind Placebo Control Crossover Pilot Study | Parkinson's Disease | Drug: Botulinum Toxin | University Health Network, Toronto | NULL | Active, not recruiting | 18 Years | N/A | Both | 14 | Phase 4 | NULL |
| 389 | NCT02202551 (ClinicalTrials.gov) | July 2014 | 25/7/2014 | Open-Label Safety Study of ADS-5102 in PD Patients With LID | Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID) | Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's Disease (PD) | Drug: ADS-5102 | Adamas Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 223 | Phase 3 | United States;Austria;Canada;France;Germany;Spain |
| 390 | ChiCTR-TRC-14004707 | 2014-06-09 | 2014-05-27 | The effect of different patterns of rehabilitation training in idiopathic Parkinson's disease | The effect of different patterns of rehabilitation training in idiopathic Parkinson's disease | Parkinson's disease | Tai Chi group:Tai Chi;Balance function training group:Balance function training; | Shanghai Tongji Hospital | NULL | Completed | 20 | 90 | Both | Tai Chi group:30;Balance function training group:30; | China | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 391 | EUCTR2013-000980-10-DK (EUCTR) | 06/06/2014 | 09/01/2014 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Austria;Denmark;Netherlands;Germany | ||
| 392 | NCT02157714 (ClinicalTrials.gov) | June 2014 | 4/6/2014 | Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease | Parkinson's Disease | Drug: PRX002;Other: Placebo | Prothena Biosciences Limited | Hoffmann-La Roche | Completed | 40 Years | 80 Years | Both | 64 | Phase 1 | United States |
| 393 | NCT02780895 (ClinicalTrials.gov) | May 2014 | 12/5/2016 | Parkinsonian Brain Repair Using Human Stem Cells | Human OK99 Allogeneic Stem Cell Transplantation for Patients With Severe Parkinson's Disease | Idiopathic Parkinson Disease | Drug: Human Stem Cells | Celavie Bioscences, LLC | Hospital Angeles del Pedregal | Active, not recruiting | 18 Years | 75 Years | Both | 8 | Phase 1 | Mexico |
| 394 | NCT02136914 (ClinicalTrials.gov) | May 2014 | 9/5/2014 | ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study) | Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study) | Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's Disease | Drug: ADS-5102;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 126 | Phase 3 | United States;Canada |
| 395 | EUCTR2013-002254-70-PL (EUCTR) | 28/04/2014 | 03/02/2014 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 396 | NCT02365012 (ClinicalTrials.gov) | April 2014 | 10/2/2015 | Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine | Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine | Orthostatic Intolerance;Parkinson's Disease | Drug: Midodrine | Philadelphia Veterans Affairs Medical Center | NULL | Recruiting | 22 Years | 89 Years | Both | 50 | N/A | United States |
| 397 | EUCTR2013-002254-70-CZ (EUCTR) | 05/03/2014 | 02/12/2013 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's DiseaseRandomizovaná, multicentrická, dvojite zaslepená, placebem kontrolovaná, 12týdenní studie fáze 3 hodnotící úcinnost perorálního istradefylinu 20 a 40 mg/den v lécbe subjektu se stredne závažnou až závažnou Parkinsonovou nemocí | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany | ||
| 398 | NCT02006121 (ClinicalTrials.gov) | March 3, 2014 | 22/11/2013 | Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease | Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment | Parkinson's Disease | Drug: Apomorphine hydrochloride;Drug: Placebo | Britannia Pharmaceuticals Ltd. | NULL | Completed | 30 Years | N/A | All | 107 | Phase 3 | Austria;Denmark;France;Germany;Netherlands;Spain;United Kingdom |
| 399 | EUCTR2013-000980-10-FR (EUCTR) | 03/03/2014 | 22/11/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | STADA Arzneimittel AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 400 | NCT02445651 (ClinicalTrials.gov) | March 2014 | 23/1/2015 | Physiological Effects of Nutritional Support in Patients With Parkinson's Disease | Physiological Effects of Nutritional Support in Patients With Parkinson's Disease | Parkinson Disease;Idiopathic Parkinson Disease | Dietary Supplement: Intravenous and Oral n-acetyl cysteine | Thomas Jefferson University | NULL | Active, not recruiting | 30 Years | 80 Years | All | 65 | N/A | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 401 | EUCTR2013-002254-70-DE (EUCTR) | 28/02/2014 | 19/11/2013 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany | ||
| 402 | EUCTR2013-002254-70-IT (EUCTR) | 21/02/2014 | 27/11/2013 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Hakko Kirin Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy | ||
| 403 | EUCTR2013-000980-10-ES (EUCTR) | 12/02/2014 | 12/11/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson?s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson?s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | STADA Arzneimittel AG | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 404 | EUCTR2013-000980-10-NL (EUCTR) | 06/02/2014 | 27/01/2014 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Germany;Netherlands | ||
| 405 | NCT02103894 (ClinicalTrials.gov) | February 2014 | 12/2/2014 | Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects | Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Clinically Diagnosed Tauopathies in Comparison to Healthy Subjects | Alzheimer's Disease (AD);Parkinson's Disease (PD);Chronic Traumatic Encephalopathy (CTE);Progressive Supranuclear Palsy (PSP);Frontal Temporal Dementia (FTD);Pick's Disease;Tauopathies | Drug: [18F]T807 ([18F]MNI-777) | Molecular NeuroImaging | Institute for Neurodegenerative Disorders | Completed | 18 Years | 85 Years | Both | 16 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 406 | EUCTR2013-002545-10-SE (EUCTR) | 08/01/2014 | 11/11/2013 | An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. | An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. - OSU6162Open1309 | Parkinsons diseaseHuntingtons diseaseMultiple sclerosBrain traumaStrokeMyalgic encephalomyelitisNarcolepsy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: OSU6162 similar to (-)-OSU 6162 | A. Carlsson Research AB | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Sweden | ||
| 407 | NCT02384512 (ClinicalTrials.gov) | January 2014 | 4/3/2015 | Azilect® In Wearing-Off (AIWO) | Azilect® In Wearing-Off (AIWO) Non-interventional Study on Efficacy and Tolerability of Rasagiline (1mg/d) add-on in Ambulatory Parkinson's Disease Patients With Wearing-off Symptoms Diagnosed by Wearing-off Questionnaire (WOQ-32) | Parkinson's Disease | Drug: Azilect® | Teva Pharma GmbH | Anfomed GmbH | Completed | 18 Years | N/A | Both | 261 | N/A | Germany |
| 408 | NCT01883505 (ClinicalTrials.gov) | December 2013 | 9/6/2013 | A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 | A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612 | Parkinson's Disease | Drug: Levodopa and carbidopa;Drug: Placebo | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 30 | Phase 2 | Israel |
| 409 | NCT04044547 (ClinicalTrials.gov) | November 22, 2013 | 30/7/2019 | A Study of LY03003 in Patients With Early-stage Parkinson's Disease | A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections | Parkinson Disease | Drug: Rotigotine, extended-release microspheres;Drug: Placebo, extended-release microspheres | Luye Pharma Group Ltd. | Beijing Bozhiyin T&S Co., Ltd. | Completed | 18 Years | 75 Years | All | 60 | Phase 1 | NULL |
| 410 | NCT01927055 (ClinicalTrials.gov) | November 2013 | 16/8/2013 | A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy | A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy | Symptomatic Neurogenic Orthostatic Hypotension;Parkinson's Disease;Multiple Systems Atrophy;Pure Autonomic Failure;Dopamine Beta Hydroxylase Deficiency | Drug: Droxidopa;Drug: Placebo | Chelsea Therapeutics | NULL | Terminated | 18 Years | N/A | All | 61 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 411 | EUCTR2013-000980-10-AT (EUCTR) | 18/10/2013 | 31/07/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 412 | NCT02055274 (ClinicalTrials.gov) | October 2013 | 31/1/2014 | Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease | A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections | Parkinson's Disease | Drug: LY03003;Drug: Neupro | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | N/A | Both | 39 | Phase 1 | United States |
| 413 | EUCTR2011-002827-17-SK (EUCTR) | 17/09/2013 | 04/03/2013 | A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. | A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. | Early stage Parkinson's Disease. MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Local Trade Name, 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Local Trade Name, 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Local Trade Name, 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | United States;Estonia;Slovakia;Russian Federation;Korea, Republic of | |||
| 414 | NCT01923584 (ClinicalTrials.gov) | September 2013 | 13/8/2013 | A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease | A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease | Parkinson's Disease | Drug: EPI-743 400mg;Drug: EPI-743 200mg | University of South Florida | Edison Pharmaceuticals Inc | Completed | 40 Years | 75 Years | Both | 15 | Phase 2 | United States |
| 415 | NCT01955616 (ClinicalTrials.gov) | September 2013 | 25/9/2013 | A Phase 2 Study to Evaluate the Safety and Efficacy of RM-131 in Patients With Parkinson's Disease & Chronic Constipation | A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Parallel Group Study to Evaluate the Pharmacodynamics, Efficacy and Safety of RM-131 Administered to Patients With Parkinson's Disease and Chronic Constipation Dissatisfied With Current Therapy | Parkinson's Disease | Drug: RM-131;Drug: Placebo | Motus Therapeutics, Inc. | Michael J. Fox Foundation for Parkinson's Research | Terminated | 18 Years | 80 Years | Both | 18 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 416 | NCT01929317 (ClinicalTrials.gov) | August 28, 2013 | 22/8/2013 | A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients. | A Study ROP116991, Clinical Evaluation of 18 to 24mg/Day Ropinirole CR for Parkinson's Disease. | Parkinson Disease | Drug: Ropinirole CR 2mg tablet;Drug: Ropinirole CR 8mg tablet;Drug: Ropinirole CR matching Placebo tablet | GlaxoSmithKline | NULL | Terminated | 20 Years | N/A | All | 81 | Phase 3 | Japan |
| 417 | NCT01767129 (ClinicalTrials.gov) | July 2013 | 9/1/2013 | Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients | A Phase 2a, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients. | Dyskinesia;Parkinson's Disease | Drug: AVP-923-45;Drug: Placebo | Avanir Pharmaceuticals | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | 80 Years | All | 14 | Phase 2 | United States;Canada |
| 418 | JPRN-JapicCTI-132189 | 01/6/2013 | 12/07/2013 | A Phase 1 Study of ONO-2160/CD | A Phase 1 study on single oral dose administration of ONO-2160/CD in healthy adult male subjects and Parkinson's disease patients | Parkinson's disease | Intervention name : ONO-2160/CD Dosage And administration of the intervention : Oral administration Control intervention name : Levodopa/carbidopa hydrate INN of the control intervention : Levodopa/Carbidopa Hydrate Dosage And administration of the control intervention : Oral administration | ONO PHARMACEUTICAL CO.,LTD. | NULL | BOTH | 42 | Phase 1 | NULL | |||
| 419 | NCT01765257 (ClinicalTrials.gov) | June 2013 | 8/1/2013 | Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study | Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study. | Drug-naïve Patients With Parkinson's Disease;Apathy | Drug: AZILECT®;Drug: Placebo | University Hospital, Clermont-Ferrand | H. Lundbeck A/S, TEVA;CHU Purpan (Toulouse);Hôpital Haut-Levêque (Pessac);Centre Hospitalier de la Côte Basque;Centre Hospitalier Universitaire de Poitiers (Poitiers);CHU de Rennes (Rennes);University Hospital, Lille;CHU Dupuytren (Limoges);University Hospital, Caen;Hôpital Caremeau (NIMES);Centre Hospitalier Pays D'Aix;Hôpital de la Timone (MARSEILLE);University Hospital, Rouen;Centre Hospitalier Universitaire, Amiens;Centre Hospitalier Universitaire de Saint Etienne;Fondation Rothschild Paris | Not yet recruiting | 30 Years | 70 Years | Both | 50 | Phase 4 | France |
| 420 | NCT02275884 (ClinicalTrials.gov) | June 2013 | 17/10/2014 | Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease | Evaluation of Plasma Concentrations of Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease | Parkinson Disease | Dietary Supplement: Dark chocolate (85% cocoa);Dietary Supplement: White chocolate (0% cocoa) | Technische Universität Dresden | University of Wuerzburg | Recruiting | 40 Years | N/A | Both | 30 | N/A | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 421 | JPRN-UMIN000010752 | 2013/05/17 | 17/05/2013 | A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia. | Parkinson's disease | donepezil | Kansai Medical University | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 50 | Not selected | Japan | |
| 422 | EUCTR2012-005822-31-IT (EUCTR) | 13/05/2013 | 20/03/2013 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) | Parkinson's Disease MedDRA version: 15.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2b | United States;Serbia;United Kingdom;Italy | ||
| 423 | NCT01851850 (ClinicalTrials.gov) | May 2013 | 1/5/2013 | Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial | Continue Providing Care for Patient Who Participated in the BIA 9-1067-302 Clinical Trial | Parkinson Disease | Drug: Opicapone | Rabin Medical Center | NULL | Completed | 30 Years | 80 Years | All | 1 | Phase 3 | Israel |
| 424 | NCT01860794 (ClinicalTrials.gov) | May 2013 | 14/5/2013 | Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease | Investigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's Disease | Idiopathic Parkinson Disease;Primary Parkinsonism | Drug: Mesencephalic Neuronal Precursor Cells | Bundang CHA Hospital | NULL | Recruiting | 18 Years | 70 Years | Female | 15 | Phase 1;Phase 2 | Korea, Republic of |
| 425 | NCT03022201 (ClinicalTrials.gov) | May 2013 | 23/11/2016 | Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease | Therapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority Trial | Parkinson's Disease,Idiopathic | Drug: DA-9701;Drug: Domperidone;Drug: Placebo domperidone;Drug: Placebo DA-9701 | Seoul National University Hospital | NULL | Completed | 20 Years | 80 Years | All | 40 | Phase 4 | Korea, Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 426 | EUCTR2011-002828-41-EE (EUCTR) | 23/04/2013 | 08/02/2013 | A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage Parkinson's disease. | A fixed dose, dose-response study of ropinirole prolonged release (PR) as adjunctive treatment to L-dopa in patients with advanced Parkinson's disease. | Advanced Parkinson's disease. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: REQUIP-MODUTAB, 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB, 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB, 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 406 | United States;Taiwan;Estonia;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of | |||
| 427 | EUCTR2011-002827-17-EE (EUCTR) | 23/04/2013 | 08/02/2013 | A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. | A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. | Early stage Parkinson's Disease. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: REQUIP-MODUTAB , 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB , 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB , 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | United States;Estonia;Slovakia;Russian Federation;Korea, Republic of | |||
| 428 | EUCTR2012-005822-31-GB (EUCTR) | 18/04/2013 | 05/03/2013 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) - Inhaled CVT-301 in Subjects with Parkinson’s Disease | Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2b | United States;Serbia;Italy;United Kingdom | ||
| 429 | JPRN-UMIN000010371 | 2013/04/08 | 01/04/2013 | Study of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease. | Parkinson's disease | Start 25mg of Zonisamide and carry out observation 24weeks. Evaluate start point, after 4weeks, after 8weeks, after 16weeks, and after 24weeks. | Department of Neurology, University of Yamanashi | NULL | Pending | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan | |
| 430 | EUCTR2012-002608-42-GB (EUCTR) | 07/04/2013 | 01/11/2012 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 478 | Phase 4 | France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 431 | NCT01777555 (ClinicalTrials.gov) | April 2013 | 23/1/2013 | Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) | Idiopathic Parkinson's Disease | Drug: CVT-301;Drug: Placebo | Acorda Therapeutics | NULL | Completed | 30 Years | 80 Years | All | 89 | Phase 2 | United States;Italy;Serbia;United Kingdom |
| 432 | NCT01829867 (ClinicalTrials.gov) | April 2013 | 9/4/2013 | A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031. | A Phase I, Open-label Study in Patients With Parkinson's Disease to Further Assess Safety and Tolerability of sNN0031 Administered at the Total Dose of 95 µg by Intracerebroventricular Infusion | Parkinson's Disease | Drug: sNN0031 | Newron Sweden AB | NULL | Terminated | 55 Years | 75 Years | Both | 5 | Phase 1 | Sweden |
| 433 | EUCTR2011-002828-41-SK (EUCTR) | 27/03/2013 | 04/03/2013 | A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage Parkinson's disease. | A fixed dose, dose-response study of ropinirole prolonged release (PR) as adjunctive treatment to L-dopa in patients with advanced Parkinson's disease. | Advanced Parkinson's disease. MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Requip Modutab, 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Requip Modutab, 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Requip Modutab, 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 406 | United States;Estonia;Taiwan;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of | |||
| 434 | NCT01780467 (ClinicalTrials.gov) | March 2013 | 21/1/2013 | Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients | Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients. | Parkinson's Disease | Behavioral: Role of dopamine | University Hospital, Clermont-Ferrand | NULL | Not yet recruiting | 35 Years | 75 Years | Both | 40 | Phase 4 | France |
| 435 | NCT01736176 (ClinicalTrials.gov) | March 2013 | 27/11/2012 | A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease | An Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's Disease | Advanced Parkinson's Disease | Drug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets | AbbVie (prior sponsor, Abbott) | NULL | Completed | 30 Years | N/A | All | 39 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 436 | EUCTR2012-002608-42-HU (EUCTR) | 10/01/2013 | 12/11/2012 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 478 | France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of | |||
| 437 | EUCTR2012-002608-42-DE (EUCTR) | 10/01/2013 | 26/09/2012 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 64 | United States;Hungary;Slovakia;Poland;Germany;United Kingdom | |||
| 438 | NCT01803945 (ClinicalTrials.gov) | January 2013 | 26/2/2013 | A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's Disease | A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: AVE8112;Drug: Placebo | Michael J. Fox Foundation for Parkinson's Research | Sanofi | Terminated | 35 Years | 70 Years | Both | 32 | Phase 1 | United States |
| 439 | EUCTR2012-002608-42-SK (EUCTR) | 17/12/2012 | 09/03/2016 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 478 | France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of | |||
| 440 | NCT02112812 (ClinicalTrials.gov) | December 2012 | 10/4/2014 | Effects of Helicobacter Pylori Infection Eradication in Patients With Parkinson's Disease | A Study on Clinical Response Following Eradication Therapy of Helicobacter Pylori Infection in Parkinson's Disease | Response to Levodopa;Motor Outcomes;Quality of Life Outcomes | Drug: Eradication therapy for H.pylori infection;Drug: Eradication of Helcobacter Pylori;Drug: Eradication therapy for Helicobacter pylori | National University of Malaysia | NULL | Completed | 17 Years | N/A | Both | 82 | N/A | Malaysia |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 441 | NCT01725802 (ClinicalTrials.gov) | December 2012 | 4/11/2012 | A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients | A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients | Parkinson's Disease | Drug: levodopa and carbidopa solution for SC administration;Drug: Placebo | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 8 | Phase 1;Phase 2 | Israel |
| 442 | NCT01683253 (ClinicalTrials.gov) | November 2012 | 7/9/2012 | Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa | The REmission of the Impulse Control Disorder and the Changes of the Neuropsychiatric Characteristics After Switching Into Levodopa/Carbidopa in Patients With Parkinson's Disease Who Have Developed Impulse Control Disorders Due to the Dopamine Replacement Therapy | Impulse Control Disorder | Drug: Levodopa/Carbidopa(200mg/50mg);Drug: Dopaminergic Agonists | Sandoz | NULL | Completed | 30 Years | 80 Years | All | 150 | Phase 4 | NULL |
| 443 | NCT01723228 (ClinicalTrials.gov) | November 2012 | 5/11/2012 | Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease | A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Teva Branded Pharmaceutical Products, R&D Inc. | NULL | Completed | 45 Years | 80 Years | All | 170 | Phase 4 | United States |
| 444 | JPRN-UMIN000009099 | 2012/10/01 | 12/10/2012 | The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia | Parkinson's disease | lidocaine injection into the external oblique normal saline injection into the external oblique | Parkinson's disease and Movement Disorder Center | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 10 | Not applicable | Japan | |
| 445 | NCT01560754 (ClinicalTrials.gov) | October 2012 | 9/3/2012 | Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease | A Randomized, Placebo-controlled, Double-blind, Multi-center Trial to Assess the Disease-modifying Potential of Transdermal Nicotine in Early Parkinson's Disease in Germany and the USA | Parkinson's Disease | Drug: nicotine transdermal patch | James BOYD MD | Michael J. Fox Foundation for Parkinson's Research;Parkinson Study Group (PSG);International Parkinson Fonds (IPF);German Parkinson Study Group (GPS);German Parkinson Society (DPG);Philipps-University Marburg, Germany | Active, not recruiting | 30 Years | N/A | Both | 160 | Phase 2 | United States;Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 446 | NCT01603069 (ClinicalTrials.gov) | October 2012 | 14/5/2012 | A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease | A Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: AZD3241 300 mg BID;Drug: AZD3241 600 mg BID;Drug: Placebo | AstraZeneca | NULL | Completed | 30 Years | 80 Years | Both | 51 | Phase 2 | United States |
| 447 | NCT01723904 (ClinicalTrials.gov) | October 2012 | 6/11/2012 | A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease | An Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3B | Advanced Parkinson's Disease | Drug: Rotigotine | UCB BIOSCIENCES GmbH | Otsuka Pharmaceutical Co., Ltd. | Completed | 30 Years | 80 Years | All | 90 | Phase 3 | Australia;Korea, Republic of;Malaysia;Singapore;Taiwan |
| 448 | EUCTR2011-004378-27-AT (EUCTR) | 04/09/2012 | 20/07/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 449 | NCT01711866 (ClinicalTrials.gov) | September 2012 | 18/10/2012 | A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease | An Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4 | Advanced Idiopathic Parkinson's Disease | Drug: Rotigotine | UCB BIOSCIENCES GmbH | Otsuka Pharmaceutical Co., Ltd. | Completed | 30 Years | 80 Years | All | 87 | Phase 4 | United States;Korea, Republic of;Malaysia;Singapore;Taiwan |
| 450 | EUCTR2011-004803-19-FI (EUCTR) | 16/08/2012 | 16/05/2012 | PET study in PD patients | A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease | Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AZD3241 Extended release tablets 25 mg Product Code: AZD3241 Product Name: AZD3241 Extended release tablets 100 mg Product Code: AZD3241 Product Name: [11C]PBR28 Product Code: [11C]PBR28 Product Name: [18F]FE-PE2I Product Code: [18F]FE-PE2I | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2A | Finland;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 451 | EUCTR2012-000122-21-DK (EUCTR) | 10/08/2012 | 07/06/2012 | Improving the blood pressure regulating system in patients with parkinsons disease | Acethylcholineesterase inhibition and orthostatic hypotension in patients with parkinsons disease | Ortostatic hypotension in patients with Parkinsons disease MedDRA version: 14.1;Level: PT;Classification code 10031127;Term: Orthostatic hypotension;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Trade Name: Mestinon Product Name: Mestinon INN or Proposed INN: PYRIDOSTIGMINE BROMIDE Other descriptive name: Mestinon | Department of Neurology, Roskilde Hospital | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Denmark | ||
| 452 | NCT00947037 (ClinicalTrials.gov) | August 2012 | 24/7/2009 | Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects | Parkinson's Disease | Drug: AP-CD/LD | Intec Pharma Ltd. | NULL | Withdrawn | 30 Years | 95 Years | Both | 0 | Phase 2 | Israel |
| 453 | JPRN-UMIN000008138 | 2012/07/01 | 01/07/2012 | Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease | Parkinson's disease | Silodosin 8mg BID | Juntendo University School of Medicine | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male | 100 | Not selected | Japan | |
| 454 | NCT01646255 (ClinicalTrials.gov) | July 2012 | 18/7/2012 | Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of The Efficacy And Safety of Rotigotine Transdermal Patch In Chinese Subjects With Advanced-stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled On Levodopa | Idiopathic Parkinson's Disease | Drug: Rotigotine;Drug: Placebo Patch;Drug: L-dopa | UCB Pharma | UCB Trading (Shanghai) Co. Ltd. | Completed | 30 Years | N/A | All | 346 | Phase 3 | China |
| 455 | NCT01646268 (ClinicalTrials.gov) | July 2012 | 18/7/2012 | Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Of The Efficacy And Safety Of The Rotigotine Transdermal Patch In Chinese Subjects With Early-stage Idiopathic Parkinson's Disease | IDIOPATHIC PARKINSON'S DISEASE | Drug: Rotigotine;Drug: Placebo Patch | UCB Pharma | NULL | Completed | 30 Years | N/A | All | 249 | Phase 3 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 456 | JPRN-JapicCTI-121880 | 11/6/2012 | Phase II clinical study in patients with Parkinson's disease not taking L-DOPA | A randomized, double-blind, placebo-controlled, comparative study of HP-3000 in patients with Parkinson's disease not taking L-DOPA | Parkinson's disease | Intervention name : HP-3000(ropinirole hydrochloride patch) Dosage And administration of the intervention : Transdermal, once daily Control intervention name : HP-3000 placebo Dosage And administration of the control intervention : Transdermal, once daily | Hisamitsu Pharmaceutical Co.,Inc. | NULL | 20 | 79 | BOTH | Phase 2 | NULL | |||
| 457 | JPRN-JapicCTI-121879 | 07/6/2012 | Phase II clinical study in patients with Parkinson's disease taking L-DOPA | A randomized, double-blind, placebo-controlled, comparative study of HP-3000 in patients with Parkinson's disease taking L-DOPA | Parkinson's disease | Intervention name : HP-3000(ropinirole hydrochloride patch) Dosage And administration of the intervention : Transdermal, once daily Control intervention name : HP-3000 placebo Dosage And administration of the control intervention : Transdermal, once daily | Hisamitsu Pharmaceutical Co.,Inc. | NULL | 20 | 79 | BOTH | Phase 2 | NULL | |||
| 458 | EUCTR2011-002074-23-AT (EUCTR) | 05/06/2012 | 07/05/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 459 | JPRN-UMIN000008057 | 2012/06/01 | 06/06/2012 | Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease | Parkinson's Disease | Daily oral administration of enteral nutrition formula (Racol NF) 400ml for 12 weeks consecutively. | St. Mariannna University School of Medicine | NULL | Complete: follow-up complete | 35years-old | 80years-old | Male and Female | 25 | Not applicable | Japan | |
| 460 | NCT02319382 (ClinicalTrials.gov) | June 2012 | 18/11/2014 | Measure of Microglial Activation in the Brain of Parkinson Disease Patients With PET | High Resolution PET Imaging of Microglial Activation in Parkinson's Disease (PD) With a New Tracer [18F]DPA-714 | Parkinson's Disease With LRRK2 Mutation;Healthy Controls;Parkinson's Disease Without LRRK2 Mutation | Radiation: PET with the tracer 18F-DPA-714;Radiation: PET with the tracer 11C-PE2I;Other: MRI | Assistance Publique - Hôpitaux de Paris | France Parkinson Association | Recruiting | 18 Years | N/A | Both | 46 | N/A | France |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 461 | EUCTR2012-001218-40-IT (EUCTR) | 21/05/2012 | 23/07/2012 | EFFICACY OF ROTIGOTINE ON GAIT PERFORMANCE OF PARKINSONIAN PATIENTS | EFFICACY OF ROTIGOTINE ON GAIT PERFORMANCE OF PARKINSONIAN PATIENTS | Patients suffering for Idiopathic Parkinson’s Disease. H&Y stage > or = 2 with un-satisfactory control by on-going pharmacological therapy (Levodopa, COMT & MAO-inhibitors), characterised by an incomplete control of motor signs, in particular presence of early morning akinesia, as well as gait deficits in the morning. MedDRA version: 14.1;Level: PT;Classification code 10056242;Term: Parkinsonian gait;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: NEUPRO*7CER 4MG/24H INN or Proposed INN: rotigotina Trade Name: NEUPRO*7CER 6MG/24H INN or Proposed INN: rotigotina Trade Name: NEUPRO*7CER 8MG/24H INN or Proposed INN: rotigotina Trade Name: NEUPRO*28CER 2MG/24H INN or Proposed INN: rotigotina Trade Name: NEUPRO*28CER 4MG/24H INN or Proposed INN: rotigotina Trade Name: NEUPRO*28CER 6MG/24H INN or Proposed INN: rotigotina Trade Name: NEUPRO*28CER 8MG/24H INN or Proposed INN: rotigotina | FONDAZIONE SANTA LUCIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 462 | EUCTR2011-004378-27-DE (EUCTR) | 15/05/2012 | 24/02/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 463 | EUCTR2011-004378-27-SK (EUCTR) | 02/05/2012 | 12/04/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 464 | JPRN-UMIN000007896 | 2012/05/01 | 07/05/2012 | Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes | Parkinson's disease and other parkinsonian syndromes | The patients are given domperidone 30 mg/day for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day lactose powder is given to the patients and levodopa (250 mg)/carbidopa (25 mg) is given on the fifth day in a double-blind manner. On fourth and fifth day, motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug. The patients are given domperidone 30 mg/day (standard dose in Japan) for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day levodopa (250 mg)/carbidopa (25 mg) is given to the patients and lactose powder is given on the fifth day in a double-blind manner. Motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug. | Kansai Medical University | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 100 | Not selected | Japan | |
| 465 | NCT01617135 (ClinicalTrials.gov) | May 2012 | 7/5/2012 | Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and Off Episodes | A Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations (Off Episodes) | Idiopathic Parkinson's Disease | Drug: CVT-301;Drug: Placebo;Drug: Sinemet (carbidopa/levodopa) | Acorda Therapeutics | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | All | 25 | Phase 2 | Israel;Serbia;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 466 | EUCTR2012-000181-37-GB (EUCTR) | 25/04/2012 | 27/02/2012 | A study investigating the safety of CVT-301 in patients with Parkinson's Disease | A Randomized, Placebo-Controlled Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CVT-301 (Levodopa Inhalation Powder) in Patients with Parkinson’s Disease and Motor Response Fluctuations (Off” Episodes) | Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Trade Name: Sinemet® Product Name: SINEMET® Plus 25 mg/100 mg Tablets INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Serbia;Israel;United Kingdom | ||
| 467 | NCT01494532 (ClinicalTrials.gov) | April 2, 2012 | 1/12/2011 | A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease | A Fixed Dose, Dose-response Study of Ropinirole Prolonged Release (PR) as Adjunctive Treatment to L-dopa in Patients With Advanced Parkinson's Disease | Parkinson Disease | Drug: ropinirole/L-dopa;Drug: placebo/L-dopa | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 352 | Phase 4 | United States;Argentina;Chile;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland |
| 468 | JPRN-JapicCTI-122000 | 01/4/2012 | 02/11/2012 | Long-term study of FPF1100NW monotherapy | Long-term study on FPF1100NW monotherapy with early Parkinson's disease patients | Early Parkinson's disease | Intervention name : FPF1100NW INN of the intervention : Selegiline Dosage And administration of the intervention : oral Control intervention name : null | FP Pharmaceutical Corp. | NULL | BOTH | 130 | Phase 2 | NULL | |||
| 469 | NCT01556165 (ClinicalTrials.gov) | April 2012 | 13/3/2012 | Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China | Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China | Parkinson's Disease | Drug: rasagiline;Drug: placebo | H. Lundbeck A/S | NULL | Completed | 35 Years | N/A | All | 130 | Phase 3 | China |
| 470 | NCT01527695 (ClinicalTrials.gov) | April 2012 | 22/12/2011 | PET Study in Parkinson's Disease Patients | A Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ER tablet 25 mg AZD3241;Drug: ER tablet 100 mg AZD3241;Drug: Placebo for AZD3241 25 mg;Drug: Placebo for AZD3241 100 mg | AstraZeneca | NULL | Completed | 45 Years | 75 Years | Both | 24 | Phase 2 | Sweden |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 471 | NCT01491529 (ClinicalTrials.gov) | April 2012 | 12/12/2011 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia Agents | Drug: AFQ056;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 80 Years | All | 154 | Phase 2 | United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey |
| 472 | NCT01331122 (ClinicalTrials.gov) | April 2012 | 13/10/2010 | Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's Disease | A Phase II, Double-Blind, Placebo-Controlled Randomized Crossover Study to Assess the Clinical Benefit and Safety of Droxidopa in the Treatment of Freezing of Gait Symptoms in Patients With Parkinson's Disease | Gait Disorders, Neurologic | Drug: droxidopa | Chelsea Therapeutics | NULL | Withdrawn | 30 Years | N/A | Both | 0 | Phase 1;Phase 2 | United States;Canada |
| 473 | NCT01523301 (ClinicalTrials.gov) | April 2012 | 27/1/2012 | Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients | Double Blind, Placebo-controlled, Parallel, Multicenter, Randomized Interventional Phase IV Study to Evaluate the Efficacy of Rotigotine on Depressive Symptoms in Idiopathic Parkinson's Disease Patients | Idiopathic Parkinson's Disease | Drug: Rotigotine;Drug: Placebo | UCB Korea Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 380 | Phase 4 | Korea, Republic of |
| 474 | EUCTR2011-002074-23-ES (EUCTR) | 30/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 475 | EUCTR2011-002074-23-SK (EUCTR) | 28/03/2012 | 30/03/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 92 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 476 | EUCTR2011-004378-27-HU (EUCTR) | 28/03/2012 | 15/02/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | United States;France;Hungary;Canada;Spain;Austria;Germany;Italy | |||
| 477 | EUCTR2011-004378-27-IT (EUCTR) | 27/03/2012 | 02/03/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson's patients with L-dopa induced dyskinesias | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 65 | United States;Hungary;Canada;Spain;Austria;Germany;Italy | |||
| 478 | EUCTR2011-002074-23-HU (EUCTR) | 21/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 479 | EUCTR2011-002074-23-DE (EUCTR) | 20/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 480 | EUCTR2011-002074-23-IT (EUCTR) | 15/03/2012 | 02/03/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe Ldopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 92 | United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 481 | NCT01519882 (ClinicalTrials.gov) | March 2012 | 24/1/2012 | Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease | A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Rotigotine on Sleep Efficiency in Patients With Advanced Parkinson's Disease. | Advanced Idiopathic Parkinson's Disease | Other: Placebo;Other: Rotigotine | UCB Pharma SA | NULL | Terminated | 18 Years | N/A | All | 1 | Phase 4 | United Kingdom |
| 482 | NCT01491932 (ClinicalTrials.gov) | March 2012 | 1/12/2011 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia Agents | Drug: AFQ056 | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 129 | Phase 2 | United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey |
| 483 | EUCTR2011-004803-19-SE (EUCTR) | 22/02/2012 | 16/12/2011 | PET study in PD patients | A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease | Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AZD3241 Extended release tablets 25 mg Product Code: AZD3241 Product Name: AZD3241 Extended release tablets 100 mg Product Code: AZD3241 Product Name: [11C]PBR28 Product Code: [11C]PBR28 Product Name: [18F]FE-PE2I Product Code: [18F]FE-PE2I | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2A | Finland;Sweden | ||
| 484 | NCT01525641 (ClinicalTrials.gov) | February 2012 | 1/2/2012 | Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease | Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease | Parkinson Disease | Drug: Mirapex LA | Boehringer Ingelheim | NULL | Completed | N/A | N/A | All | 615 | N/A | Japan |
| 485 | NCT01568099 (ClinicalTrials.gov) | February 2012 | 16/3/2012 | Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease | A Randomized, Controlled, Parallel Group, Patient-blinded, Single-center, Phase I Pilot Study to Assess Tolerability and Safety of Repeated Subcutaneous Administration of Two Doses of AFFITOPE® PD01A Formulated With Adjuvant to Patients With Parkinson's Disease | Parkinson's Disease | Biological: AFFITOPE® PD01A;Other: Control | Affiris AG | NULL | Completed | 40 Years | 65 Years | Both | 32 | Phase 1 | Austria |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 486 | NCT01485172 (ClinicalTrials.gov) | January 31, 2012 | 1/12/2011 | A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease | A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release (PR) in Patients With Early Stage Parkinson's Disease | Parkinson Disease | Drug: ropinirole monotherapy;Drug: placebo monotherapy | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 186 | Phase 4 | United States;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland |
| 487 | NCT01497652 (ClinicalTrials.gov) | January 2012 | 20/12/2011 | A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy | A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy | Parkinson's Disease | Drug: Rasagiline/Placebo;Drug: Rasagiline | Georgetown University | Teva Neuroscience, Inc. | Completed | 40 Years | N/A | Both | 34 | Phase 4 | United States |
| 488 | NCT01536015 (ClinicalTrials.gov) | January 2012 | 15/2/2012 | Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction | Advanced Parkinson's Disease | Drug: Rotigotine;Drug: Placebo | UCB Pharma | NULL | Terminated | 30 Years | N/A | All | 25 | Phase 3 | United States |
| 489 | NCT01515410 (ClinicalTrials.gov) | January 2012 | 11/1/2012 | Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations | A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations | Parkinson's Disease;Motor Fluctuations | Drug: DM-1992;Drug: Sinemet IR | Depomed | NULL | Completed | 30 Years | N/A | All | 34 | Phase 2 | United States |
| 490 | NCT01470859 (ClinicalTrials.gov) | December 2011 | 9/11/2011 | The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease | a Pilot Follow-up Study of Investigating the Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Chinese Patients With Early Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: pramipexole;Drug: Sinemet CR | Huashan Hospital | Boehringer Ingelheim | Completed | 30 Years | 75 Years | All | 30 | N/A | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 491 | NCT01519271 (ClinicalTrials.gov) | December 2011 | 10/1/2012 | Mild Cognitive Impairment in Parkinson's Disease | A Phase IV Randomized, Double-Blind, Placebo-Controlled, Crossover Single Site Study Of Exelon® Patch (Rivastigmine Transdermal System) For Mild Cognitive Impairment In Parkinson's Disease | Parkinson's Disease;Mild Cognitive Impairment | Drug: Exelon Patch (rivastigmine transdermal system);Drug: Placebo Patches | University of Pennsylvania | NULL | Completed | 40 Years | 85 Years | All | 28 | Phase 4 | United States |
| 492 | NCT01479530 (ClinicalTrials.gov) | December 2011 | 22/11/2011 | Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China | Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China | Parkinson's Disease | Drug: Placebo;Drug: Azilect® | H. Lundbeck A/S | NULL | Completed | 30 Years | N/A | All | 321 | Phase 3 | China |
| 493 | NCT01351168 (ClinicalTrials.gov) | December 2011 | 9/5/2011 | Use of Zolpidem in Parkinson's Disease | A Randomized, Controlled, Double-Blind, Cross-over Study of Zolpidem for Patients With Parkinson's Disease | Parkinson's Disease | Drug: Levodopa;Drug: Zolpidem first dose;Drug: Zolpidem second dose;Drug: sugar pill | Rush University Medical Center | NULL | Withdrawn | 30 Years | 75 Years | Both | 0 | Phase 2 | United States |
| 494 | EUCTR2011-002073-30-IT (EUCTR) | 14/11/2011 | 06/03/2012 | Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 12-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson's disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10043118;Term: Tardive dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 63 | United States;European Union;Canada;Spain;Germany;Switzerland;Italy | |||
| 495 | NCT01736891 (ClinicalTrials.gov) | November 2011 | 27/11/2012 | Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations | Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China) | Parkinson´s Disease | Drug: Rasagiline;Drug: Placebo | Chongqing Fortune Pharmaceutical Co., Ltd. | Beijing Bionovo Medicine Development Co., Ltd. | Completed | 30 Years | 75 Years | Both | 268 | Phase 3 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 496 | NCT01291537 (ClinicalTrials.gov) | November 2011 | 7/2/2011 | Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients | Parkinson's Disease | Drug: Duodopa;Drug: best médical treatment | Poitiers University Hospital | NULL | Completed | 18 Years | 80 Years | Both | 56 | Phase 2 | France | |
| 497 | NCT01385592 (ClinicalTrials.gov) | November 2011 | 28/6/2011 | Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders | Drug: AFQ056;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 80 Years | Both | 78 | Phase 2 | United States;Canada;France;Germany;Hungary;Italy;Spain |
| 498 | JPRN-JapicCTI-111673 | 12/10/2011 | 25/10/2011 | Phase II clinical study in patients with Parkinson's disease. | Pharmacokinetic study of HP-3000 in patients with Parkinson's disease. | Parkinson's disease | Intervention name : HP-3000 (ropinirole hydrochloride patch) Dosage And administration of the intervention : Transdermal, once daily | Hisamitsu Pharmaceutical Co., Inc. | NULL | 20 | 79 | BOTH | Phase 2 | NULL | ||
| 499 | EUCTR2011-000056-42-GB (EUCTR) | 07/10/2011 | 11/08/2011 | Sleep efficiency assessed by Polysomnography (PSG sleep lab testing) in advanced Parkinson's disease | A MULTI-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECTS OF ROTIGOTINE ON SLEEP EFFICIENCY IN PATIENTS WITH ADVANCED PARKINSON’S DISEASE - sleep efficiency assessed by polysomnography in advanced Parkinson's Disease | Advanced Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Celltech, UK - Registered Branch of UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 500 | JPRN-UMIN000006521 | 2011/10/01 | 11/10/2011 | Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease | Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease - Switch trial from IR to ER of Pramipexole | Parkinson's disease | Rapid switch of Pramipexole ER (once in a day) which is same dose as IR. The period of administration is 8 weeks. | Department of Neurology, Juntendo University | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 501 | NCT01446614 (ClinicalTrials.gov) | October 2011 | 4/10/2011 | Mesenchymal Stem Cells Transplantation to Patients With Parkinson's Disease | Phase?/?Trial of Autologous Bone Marrow Derived Mesenchymal Stem Cells to Patients With Parkinson's Disease. | Parkinson's Disease | Biological: bone marrow derived mesenchymal stem cells | Guangzhou General Hospital of Guangzhou Military Command | NULL | Recruiting | 30 Years | 65 Years | Both | 20 | Phase 1;Phase 2 | China |
| 502 | NCT01474421 (ClinicalTrials.gov) | September 15, 2011 | 5/10/2011 | Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias | Dyskinesias;Drug-induced | Drug: AQW051;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 85 Years | All | 71 | Phase 2 | United States;France;Germany;Italy |
| 503 | NCT01515774 (ClinicalTrials.gov) | September 2011 | 10/1/2012 | Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID) | An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson Disease | Parkinson's Disease | Drug: Mirapex ER | Seoul National University Hospital | NULL | Recruiting | 30 Years | 80 Years | Both | 200 | Phase 4 | Korea, Republic of |
| 504 | NCT01178047 (ClinicalTrials.gov) | September 2011 | 6/8/2010 | Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease | A Multicenter, Randomized, Double-blind Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease (PD) | Parkinson's Disease | Drug: Rasagiline | University of Zurich | H. Lundbeck A/S | Terminated | 40 Years | N/A | Both | 1 | Phase 4 | Switzerland |
| 505 | NCT01545856 (ClinicalTrials.gov) | September 2011 | 2/2/2012 | Cardiovascular Events in Parkinson's Disease Patients | Background Incidence of Cardiovascular Ischaemic Events in Treated Parkinson's Disease Patients in the Impact Database | Cardiovascular Event;Parkinson Disease | Drug: levodopa | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 1 | N/A | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 506 | EUCTR2010-020299-42-DE (EUCTR) | 30/08/2011 | 26/04/2011 | A study in U.S. and Germany to show if patients with an early stage of Parkinson's disease could be treated with a nicotine patch. In this study the nicotine patch is being compared to a placebo patch. The placebo patch is identical in appearance to the nicotine patch but does not contain any active ingredients. | A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD) - NIC-PD | Early PD subjects within 18 months of diagnosis and not expected to require dopamine agonist or levodopa therapy for 1 year, with Hoehn and Yahr stage <2, with stable (>2 months) MAO-B inhibitor therapy allowed MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Nicotinell 17,5 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE Trade Name: Nicotinell 35 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE | Philipps-University Marburg | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Germany | ||
| 507 | EUCTR2010-021394-37-BG (EUCTR) | 04/08/2011 | 02/06/2011 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 508 | EUCTR2010-021860-13-BG (EUCTR) | 04/08/2011 | 02/06/2011 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina | |||
| 509 | NCT01759888 (ClinicalTrials.gov) | August 2011 | 1/1/2013 | Development of a Novel 18F-DTBZ PET Imaging as a Biomarker to Monitor Neurodegeneration of PARK6 and PARK8 Parkinsonism | From Mouse Models to Patients: Development of a Novel 18F-DTBZ PET Imaging as a Biomarker to Monitor Neurodegeneration of PARK6 and PARK8 Parkinsonism | Parkinson's Disease | Drug: 18F-DTBZ | Chang Gung Memorial Hospital | National Science Council, Taiwan | Completed | 20 Years | 80 Years | Both | 49 | Phase 2 | Taiwan |
| 510 | NCT01370811 (ClinicalTrials.gov) | August 2011 | 8/6/2011 | A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease | A Phase II, Double-blind, Randomized, Placebo-controlled 4-way Crossover Study to Evaluate the Relative Efficacy and Safety of OC Oral Solution (Oxybutynin and Clonidine) for Sialorrhoea in Patients With Parkinson's Disease | Sialorrhoea | Drug: OC oral solution treatment A;Drug: OC oral solution treatment B;Drug: OC oral solution treatment C;Drug: OC oral solution treatment D | Orient Pharma Co., Ltd. | NULL | Completed | 40 Years | 80 Years | Both | 24 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 511 | EUCTR2010-021860-13-IT (EUCTR) | 25/07/2011 | 29/03/2012 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF` PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF`PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson`s Disease (PD) and end-of-dose motor fluctuations MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Trade Name: Comtan® INN or Proposed INN: NA | BIAL - PORTELA & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Slovakia;Spain;Lithuania;Austria;Russian Federation;Italy;Hungary;Czech Republic;Romania;Croatia;Bulgaria;Latvia;Germany;Bosnia and Herzegovina | |||
| 512 | EUCTR2011-001092-39-DE (EUCTR) | 29/06/2011 | 17/05/2011 | efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias | A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesiasin Parkinson’s patients with moderate to severe L-dopa induced dyskinesias | L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias MedDRA version: 14.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AQW051 Product Code: AQW051 Product Name: AQW051 Product Code: AQW051 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | France;United States;Germany;Italy | |||
| 513 | EUCTR2010-021860-13-CZ (EUCTR) | 24/06/2011 | 09/11/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa L-DOPA/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina | |||
| 514 | EUCTR2010-022200-46-LV (EUCTR) | 21/06/2011 | 01/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®) in patients with Pakinson's disease. | Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®); a randomised, double-blind, crossover, proof of conceptstudy in patients with Parkinson's disease and end-of-dose motorfluctuations. - PARPOC | Parkinson's disease MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Germany;Latvia | |||
| 515 | NCT01652534 (ClinicalTrials.gov) | June 2011 | 15/8/2011 | Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease | Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Amantadine;Drug: Placebo | Northwestern University | NULL | Terminated | 18 Years | 85 Years | All | 3 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 516 | NCT02253563 (ClinicalTrials.gov) | June 2011 | 24/9/2014 | Resistance Versus Balance Training in Parkinson's Disease | Resistance Training Versus Balance Training to Improve Postural Control in Patients With Parkinson's Disease - a Randomized Controlled Rater Blinded Trial | Parkinson's Disease | Behavioral: Resistance Training;Behavioral: Balance Training | University of Kiel | NULL | Completed | 40 Years | 100 Years | Both | 40 | N/A | NULL |
| 517 | EUCTR2010-022517-25-DE (EUCTR) | 30/05/2011 | 14/02/2011 | Safety, tolerability and efficacy of ADX48621 in patients with Parkinson's disease | Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease | Levodopa induced dyskinesia in Parkinson's disease patients MedDRA version: 13.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ADX48621 Product Code: ADX48621 INN or Proposed INN: Dipraglurant | Addex Pharma SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | United States;France;Austria;Germany | ||
| 518 | EUCTR2008-005492-94-BG (EUCTR) | 25/05/2011 | 23/03/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 519 | EUCTR2010-021394-37-AT (EUCTR) | 19/05/2011 | 05/01/2011 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland | ||
| 520 | EUCTR2010-022200-46-FI (EUCTR) | 13/05/2011 | 23/03/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Germany;Latvia;Lithuania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 521 | EUCTR2010-022200-46-LT (EUCTR) | 09/05/2011 | 05/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Germany;Latvia | |||
| 522 | EUCTR2007-002964-90-BE (EUCTR) | 05/05/2011 | 04/09/2007 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Slovakia;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Belgium;Malaysia;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 523 | EUCTR2010-021394-37-SK (EUCTR) | 02/05/2011 | 16/12/2010 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 524 | NCT01361009 (ClinicalTrials.gov) | May 2011 | 23/5/2011 | a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients | Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance | Parkinson Disease | Drug: pramipexole | Boehringer Ingelheim | NULL | Completed | 30 Years | 75 Years | All | 2017 | N/A | China |
| 525 | NCT01766258 (ClinicalTrials.gov) | May 2011 | 22/11/2012 | Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations | Efficacy and Safety of ODM-101 Compared to a Standard Combination (Stalevo®); a Randomised, Double-blind, Crossover, Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations | Parkinson's Disease | Drug: ODM-101 65mg Carbidopa;Drug: ODM-101 105mg Carbidopa;Drug: Stalevo | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | Both | 117 | Phase 2 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 526 | NCT01856439 (ClinicalTrials.gov) | May 2011 | 14/5/2013 | Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease | A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease. | Parkinson's Disease | Drug: ProSavin | Axovant Sciences Ltd. | Oxford BioMedica | Active, not recruiting | N/A | N/A | All | 15 | Phase 1;Phase 2 | France;United Kingdom |
| 527 | EUCTR2010-022366-27-CZ (EUCTR) | 21/04/2011 | 23/11/2010 | BIPARK STUDY II | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic Parkinson's Disease MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India | |||
| 528 | EUCTR2010-022366-27-BE (EUCTR) | 18/04/2011 | 01/02/2011 | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic Parkinson's Disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Phase 3 | Czech Republic;Estonia;Belgium;United Kingdom | ||
| 529 | EUCTR2010-022517-25-AT (EUCTR) | 15/04/2011 | 17/02/2011 | Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease | Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease | Levodopa induced dyskinesia in Parkinson's disease patients MedDRA version: 14.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ADX48621 Product Code: ADX48621 INN or Proposed INN: Dipraglurant | Addex Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;France;Austria;Germany | ||
| 530 | EUCTR2008-005492-94-PT (EUCTR) | 14/04/2011 | 19/01/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 531 | NCT01338896 (ClinicalTrials.gov) | April 2011 | 18/4/2011 | Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations | A Multicenter, Randomized, Double-blind, Two-way Cross-over Study to Compare the Adhesiveness of Two Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine transdermal patch | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 56 | Phase 1 | Austria;Germany;United Kingdom |
| 532 | NCT01662414 (ClinicalTrials.gov) | April 2011 | 7/8/2012 | Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease | Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease: Changes in Biomarkers of Oxidative Stress, Profiles of Plasma Amino Acids and Their Derivatives and Brain Function | Parkinson Disease;Parkinsonian Disorders;Basal Ganglia Diseases;Brain Diseases;Central Nervous System Diseases;Nervous System Diseases;Movement Disorders;Neurodegenerative Diseases | Dietary Supplement: Whey protein;Dietary Supplement: Soy protein | Chulalongkorn University | NULL | Completed | 30 Years | 80 Years | Both | 38 | Phase 4 | Thailand |
| 533 | NCT01336088 (ClinicalTrials.gov) | April 2011 | 4/4/2011 | ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease | Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ADX48621;Drug: Placebo | Addex Pharma S.A. | NULL | Completed | 30 Years | 75 Years | Both | 83 | Phase 2 | United States;Austria;France;Germany |
| 534 | EUCTR2010-022366-27-GB (EUCTR) | 23/03/2011 | 30/11/2010 | BIPARK STUDY II | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic Parkinson's Disease MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Phase 3 | Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India | ||
| 535 | EUCTR2008-005492-94-CZ (EUCTR) | 14/03/2011 | 03/01/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Portugal;United States;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 536 | EUCTR2010-021860-13-DE (EUCTR) | 09/03/2011 | 18/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina | |||
| 537 | EUCTR2010-021394-37-CZ (EUCTR) | 09/03/2011 | 14/12/2010 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Hungary;Czech Republic;Spain;Belgium;Austria;Germany;Italy;Switzerland | ||
| 538 | EUCTR2010-021394-37-DE (EUCTR) | 08/03/2011 | 03/12/2010 | Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 539 | EUCTR2008-005492-94-FI (EUCTR) | 04/03/2011 | 13/01/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 540 | NCT01283594 (ClinicalTrials.gov) | March 2011 | 24/1/2011 | Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off | A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off | Parkinson's Disease | Drug: Tozadenant (SYN115) 60 mg BID;Drug: Placebo;Drug: Levodopa (L-dopa);Drug: Tozadenant (SYN115) 120 mg BID;Drug: Tozadenant (SYN115) 180 mg BID;Drug: Tozadenant (SYN115) 240 mg BID | Biotie Therapies Inc. | NULL | Completed | 30 Years | 80 Years | All | 420 | Phase 2;Phase 3 | United States;Argentina;Canada;Chile;Romania;Ukraine |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 541 | NCT01264861 (ClinicalTrials.gov) | March 2011 | 20/12/2010 | A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging | Open-Label Escalating Dose Study Using [123|]ß-CIT SPECT Single Photon Emission Computerized Tomography (SPECT) to Evaluate Dopamine and Serotonin Transporter Occupancy by Safinamide in Parkinson Disease Patients | Parkinson Disease | Drug: Safinamide | Newron | NULL | Terminated | 40 Years | 80 Years | All | 5 | Phase 2 | United States |
| 542 | NCT01330290 (ClinicalTrials.gov) | March 2011 | 18/3/2011 | Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support | A Multi-site, Non-interventional, Cross-sectional Evaluation of the Caregivers' and the Physicians' Preferred Route of Administration and the Physicians' Rationale for the Choice of Neupro® in Patients With Parkinson Requiring Caregiver Support | Idiopathic Parkinson's Disease | Drug: Neupro® | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 148 | N/A | Germany |
| 543 | NCT01568073 (ClinicalTrials.gov) | March 2011 | 29/3/2012 | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical Study | Parkinson's Disease | Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: Benserazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | 83 Years | All | 600 | Phase 3 | Portugal;Austria |
| 544 | NCT01227655 (ClinicalTrials.gov) | March 2011 | 22/10/2010 | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients. | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study. | Parkinson's Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: Benserazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | 83 Years | All | 427 | Phase 3 | Portugal |
| 545 | NCT01294800 (ClinicalTrials.gov) | February 25, 2011 | 10/2/2011 | A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402) | A Phase 2, 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Preladenant in Japanese Subjects With Moderate to Severe Parkinson's Disease. (Phase 2; Protocol No. P06402) | Parkinson's Disease | Drug: Preladenant;Drug: Placebo tablet to match Preladenant | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | 85 Years | All | 450 | Phase 2 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 546 | EUCTR2010-022363-35-DE (EUCTR) | 18/02/2011 | 19/10/2010 | Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial. | Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial. | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Madopar LT Product Name: Levodopa / Benserazid Product Code: LD / BE INN or Proposed INN: LEVODOPA Other descriptive name: - INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE Other descriptive name: - Trade Name: Neupro Product Name: Rotigotin Product Code: RO INN or Proposed INN: ROTIGOTINE Other descriptive name: - | Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 547 | EUCTR2010-021860-13-SK (EUCTR) | 17/02/2011 | 09/12/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina | |||
| 548 | EUCTR2010-021394-37-ES (EUCTR) | 17/02/2011 | 22/12/2010 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976 | Enfermedad de Parkinson MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: NEUPRO 2 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 4 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 6 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 8 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE | UCB Pharma SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 345 | Phase 4 | Hungary;Czech Republic;Germany;Belgium;Spain;Italy;Austria | ||
| 549 | EUCTR2010-021394-37-HU (EUCTR) | 14/02/2011 | 13/12/2010 | Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinson’s disease | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland | ||
| 550 | EUCTR2009-017174-20-AT (EUCTR) | 09/02/2011 | 07/12/2010 | A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease. | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study | Idiopathic Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015E, EMD 1195686, MSC2191632B INN or Proposed INN: safinamide Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 24 | Germany;Canada;France;Austria;South Africa | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 551 | NCT02880033 (ClinicalTrials.gov) | February 2011 | 3/8/2016 | Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes | Modulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral Sclerosis | Parkinson's Disease;Amyotrophic Lateral Sclerosis;Oxidative Stress;Iron Overload | Drug: deferiprone;Drug: placebo | University Hospital, Lille | NULL | Completed | 18 Years | 80 Years | All | 90 | N/A | France |
| 552 | NCT01296464 (ClinicalTrials.gov) | February 2011 | 14/2/2011 | Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens | Duration of Motor Response After Administration of Experimental Levodopa/Carbidopa/Entacapone Treatment Regimens Compared to Standard Treatment (Stalevo®);a Randomised,Double-blind,Crossover,Multicentre,Single Dose Study in Patients With Parkinson?s Disease and Wearing-off Symptoms | Parkinson's Disease | Drug: Carbidopa | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | Both | 27 | Phase 2 | Finland;Sweden |
| 553 | NCT01300819 (ClinicalTrials.gov) | February 2011 | 18/2/2011 | Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms | Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Other: Placebo;Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 349 | Phase 4 | Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Hungary;Italy;Romania;Slovakia;Spain;Switzerland |
| 554 | NCT01313845 (ClinicalTrials.gov) | February 2011 | 10/3/2011 | Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease | Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease | Parkinson's Disease | Drug: amantadine sulfate;Drug: 0.9% sodium chloride | Jee-Young Lee | Seoul National University Boramae Hospital;Samsung Medical Center;Seoul National University Bundang Hospital;Hanyang University | Completed | 30 Years | 79 Years | Both | 46 | Phase 4 | Korea, Republic of |
| 555 | EUCTR2010-021860-13-AT (EUCTR) | 27/01/2011 | 11/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Germany;Latvia;Netherlands;Bosnia and Herzegovina | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 556 | EUCTR2010-021860-13-RO (EUCTR) | 27/01/2011 | 25/07/2011 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Montenegro;Italy;Latvia;Austria;Lithuania;Slovakia;Russian Federation;Czech Republic;Ukraine;Serbia;Romania;Spain;Bosnia and Herzegovina;Croatia;Poland | |||
| 557 | EUCTR2010-021394-37-BE (EUCTR) | 25/01/2011 | 14/12/2010 | Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 558 | EUCTR2010-021860-13-ES (EUCTR) | 24/01/2011 | 27/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations.Adjunto a levodopa/inhibidor dopa descarboxilasa para pacientes con enfermedad de Parkinson y fluctuaciones motoras de fin de dosis MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy | |||
| 559 | EUCTR2010-022915-21-SE (EUCTR) | 12/01/2011 | 18/11/2010 | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 27 | Finland;Sweden | |||
| 560 | EUCTR2010-022915-21-FI (EUCTR) | 10/01/2011 | 11/11/2010 | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 27 | Finland;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 561 | NCT01489982 (ClinicalTrials.gov) | January 2011 | 19/7/2011 | Treatments for Insomnia in Patients With Parkinson's Disease | Treatments for Insomnia in Patients With Parkinson's Disease: A Pilot Study | Parkinson's Disease;Insomnia | Device: Light box (Litebook company);Behavioral: CBT and sleep hygiene;Drug: Doxepin and Zopiclone;Device: Light box ( Litebook company) | McGill University Health Center | NULL | Completed | 18 Years | N/A | Both | 20 | Phase 0 | Canada |
| 562 | NCT01229332 (ClinicalTrials.gov) | January 2011 | 3/10/2010 | A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients | A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: Saline;Drug: Carbidopa | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 24 | Phase 1;Phase 2 | Israel |
| 563 | NCT01340885 (ClinicalTrials.gov) | January 2011 | 19/4/2011 | Cognitive Decline in Non-demented PD | Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study | Parkinson's Disease | Drug: Strattera;Drug: Exelon;Other: Placebo | Oregon Health and Science University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | N/A | All | 9 | Phase 4 | United States |
| 564 | NCT01268891 (ClinicalTrials.gov) | January 2011 | 30/12/2010 | Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea | Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in Korea | Parkinson's Disease | Drug: Placebo;Drug: Azilect® | H. Lundbeck A/S | NULL | Completed | 30 Years | N/A | All | 132 | Phase 3 | Korea, Republic of |
| 565 | EUCTR2010-021860-13-LV (EUCTR) | 22/12/2010 | 14/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 566 | EUCTR2010-021860-13-PT (EUCTR) | 22/12/2010 | 08/11/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina | |||
| 567 | EUCTR2008-004146-88-DE (EUCTR) | 20/12/2010 | 15/10/2010 | An extension trial to investigate the long-term efficacy and safety of safinamide, as an add-on-therapy in patients with early Parkinson´s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;United States;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 568 | EUCTR2010-022366-27-EE (EUCTR) | 10/12/2010 | 03/11/2010 | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic Parkinson's Disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Czech Republic;Estonia;Belgium;United Kingdom | |||
| 569 | EUCTR2010-021860-13-LT (EUCTR) | 30/11/2010 | 28/09/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Croatia;Romania;Bulgaria;Latvia;Germany;Netherlands;Bosnia and Herzegovina | |||
| 570 | EUCTR2010-020109-34-ES (EUCTR) | 29/11/2010 | 23/09/2010 | Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment. | Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment. | Cognition in non-demented patients with idiopathic Parkinson's disease Cognición en sujetos no dementes con Enfermedad de Parkinson idiopática MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamida Product Code: NW-1015 Other descriptive name: Safinamida | Merck Serono S.A. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Spain;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 571 | EUCTR2010-020109-34-IT (EUCTR) | 24/11/2010 | 27/12/2010 | A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND | A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND | Cognition in non-demented patients with idiopathic Parkinson’s disease MedDRA version: 9.1;Level: PT;Classification code 10061536 | Product Name: SAFINAMIDE Product Code: NW-1015 | MERCK SERONO SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Spain;Italy | ||
| 572 | EUCTR2010-021860-13-HU (EUCTR) | 11/11/2010 | 27/09/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy | |||
| 573 | EUCTR2007-001109-26-GB (EUCTR) | 04/11/2010 | 05/08/2010 | A phase I/II study of the safety, efficacy and dose evaluation of ProSavin®, administered using stereotactic injection to the striatum of patients with bilateral, idiopathic Parkinson’s disease | A phase I/II study of the safety, efficacy and dose evaluation of ProSavin®, administered using stereotactic injection to the striatum of patients with bilateral, idiopathic Parkinson’s disease | Patients with bilateral, idiopathic Parkinson's Disease | Oxford BioMedica (UK) Ltd | NULL | Not Recruiting | Female: yes Male: yes | 27 | Phase 1;Phase 2 | United Kingdom | |||
| 574 | NCT01190553 (ClinicalTrials.gov) | November 2010 | 26/8/2010 | Pilot Study of Maintenance Therapy With Intravenous AMANTADINE | Maintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson Medications | Parkinson Disease | Drug: Amantadine | Rabin Medical Center | NULL | Not yet recruiting | 30 Years | 80 Years | Both | 20 | N/A | NULL |
| 575 | EUCTR2010-019418-25-DE (EUCTR) | 01/10/2010 | 19/07/2010 | Open label, safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 16.0;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065 | Novartis Pharma Sevices AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | France;Canada;Finland;Australia;Germany;Italy;Japan | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 576 | NCT01192529 (ClinicalTrials.gov) | October 2010 | 30/8/2010 | Evaluation of a Diet in Patients With Senile Dementia | Clinical Evaluation of an Specific Diet for People With Dementia Disease | Alzheimer's Disease;Parkinson's Disease;Senile Dementia | Dietary Supplement: Supressi. T-Diet plus Range;Dietary Supplement: High Protein. T-Diet plus Range | Vegenat, S.A. | NULL | Recruiting | 70 Years | N/A | Both | 184 | N/A | Spain |
| 577 | NCT01173731 (ClinicalTrials.gov) | October 2010 | 28/7/2010 | Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | Parkinson Disease;Dyskinesia, Drug-Induced;Levodopa | Drug: AFQ056 | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 66 | Phase 2 | United States;Australia;Canada;France;Germany;Italy;Finland;Spain |
| 578 | NCT01216904 (ClinicalTrials.gov) | October 2010 | 6/10/2010 | Nicotine Treatment of Impulsivity in Parkinson's Disease | Nicotine Treatment of Impulsivity in Parkinson's Disease: A Pilot Study | Parkinson's Disease | Drug: nicotine patch;Drug: placebo | University of Vermont | Parkinson's Disease Foundation;The Parkinson Study Group | Recruiting | 18 Years | N/A | Both | 20 | Phase 4 | United States |
| 579 | EUCTR2010-019418-25-FR (EUCTR) | 29/09/2010 | 15/07/2010 | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | France;Finland;Germany;Italy | |||
| 580 | EUCTR2010-019418-25-FI (EUCTR) | 08/09/2010 | 21/07/2010 | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | France;Finland;Germany;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 581 | NCT01211587 (ClinicalTrials.gov) | September 2010 | 28/9/2010 | A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease | A Double-blind, Randomized, Placebo-controlled, Parallel-group Phase II Study to Explore the Potential Beneficial Effects of Safinamide on Cognition in Non-demented Patients With Idiopathic Parkinson's Disease (PD) and Cognitive Impairment | Parkinson's Disease With Cognitive Impairments | Drug: safinamide;Drug: placebo | Newron | NULL | Completed | 45 Years | 80 Years | Both | 103 | Phase 2 | United States;Spain |
| 582 | NCT01162226 (ClinicalTrials.gov) | September 2010 | 24/6/2010 | Computer-Based Balance Training for People With Parkinson's Disease | PD Wii: Computer-based Gait and Balance Training for Parkinson's Patients. | Parkinson's Disease | Behavioral: gait and balance training program | University of California, San Francisco | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | N/A | N/A | Both | 62 | Phase 2 | United States |
| 583 | EUCTR2009-017253-35-GB (EUCTR) | 20/08/2010 | 06/08/2010 | Long-term study of patients who received ProSavin in the PS1/001/07 clinical trial. | A multicentre, open-label extension study to determine the long term safety, tolerability and efficacy of ProSavin® in patients with bilateral, idiopathic Parkinson’s disease | Patients with bilateral, idiopathic Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ProSavin INN or Proposed INN: ProSavin | Oxford BioMedica (UK) Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 27 | United Kingdom | |||
| 584 | NCT01191944 (ClinicalTrials.gov) | August 2010 | 30/8/2010 | Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients | A Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With Levodopa | Parkinson Disease | Drug: pramipexole immediate release tablet;Drug: pramipexole extended release tablet | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 475 | Phase 3 | China |
| 585 | NCT01785628 (ClinicalTrials.gov) | August 2010 | 24/6/2011 | The Impact of Pharmacological and Electric Modulation of NMDA Pathway on the Cognitive Flexibility and Volitional Movement Preparation in Patients With Parkinson's Disease | Parkinson's Disease With Dementia | Dietary Supplement: Sarcosine Capsule;Dietary Supplement: Placebo Capsule | China Medical University Hospital | National Science Council, Taiwan | Completed | N/A | N/A | All | 30 | N/A | Taiwan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 586 | EUCTR2010-018650-12-FR (EUCTR) | 13/07/2010 | 06/05/2010 | Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX | Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX | maladie de Parkinson MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: CYMBALTA Product Name: duloxetine Trade Name: APOKINON Product Name: apomorphine Trade Name: MODOPAR Product Name: levodopa Trade Name: MOTILIUM Product Name: dompéridone | CHU de Toulouse | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | France | |||
| 587 | NCT01149811 (ClinicalTrials.gov) | July 2010 | 10/6/2010 | A Study Comparing the Safety and Tolerability of Two Doses of Fipamezole in Adult Patients With Parkinson's Disease | A Randomized, Double-Blind, Crossover Study Comparing the Safety and Tolerability of Two Dose Regimens of Oromucosal Fipamezole ODT in Adult Patients With Parkinson's Disease Who Are Receiving Levodopa | Parkinson's Disease | Drug: Fipamezole ODT;Drug: Fipamezole ODT Cohort 2 | Valeant Pharmaceuticals International, Inc. | NULL | Completed | 30 Years | 75 Years | Both | 27 | United States | |
| 588 | NCT01174004 (ClinicalTrials.gov) | July 2010 | 30/7/2010 | A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease | Parkinson's Disease Psychosis | Drug: pimavanserin tartrate;Drug: placebo | ACADIA Pharmaceuticals Inc. | NULL | Completed | 40 Years | N/A | All | 199 | Phase 3 | United States;Canada |
| 589 | NCT01174810 (ClinicalTrials.gov) | July 2010 | 2/8/2010 | Exendin-4 as a Treatment for Parkinson's Disease - Pilot Study | An Open Label, Single Site, 12 Month, Phase II, Randomised Controlled Trial Evaluating the Safety and Efficacy of Exendin-4 (Exenatide) in the Treatment of Patients With Moderate Severity Parkinson's Disease. | Parkinson's Disease | Drug: Exenatide | University College, London | NULL | Active, not recruiting | 45 Years | 70 Years | Both | 40 | Phase 2 | United Kingdom |
| 590 | NCT01176240 (ClinicalTrials.gov) | June 2010 | 30/7/2010 | A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease | A Multi-center, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease | Orthostatic Hypotension;Parkinson's Disease | Drug: Droxidopa;Other: Placebo | Chelsea Therapeutics | NULL | Completed | 18 Years | N/A | All | 225 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 591 | EUCTR2010-018904-94-IT (EUCTR) | 31/05/2010 | 14/03/2012 | EFFICACY AND SAFETY OF INTRAMUSCULAR NERIDRONATE IN OSTEOPOROTIC PATIENTS AFFECTED BY PARKINSON'S DISEASE | EFFICACY AND SAFETY OF INTRAMUSCULAR NERIDRONATE IN OSTEOPOROTIC PATIENTS AFFECTED BY PARKINSON'S DISEASE | Osteoporosis in patients affected by Parkinson's disaease at the stages 1-2-3-4 following Hoehn and Yahr criteria MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: NERIXIA*IM EV 1F 25MG INN or Proposed INN: Bisphosphonates Other descriptive name: Neridronic acid | FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 592 | EUCTR2010-019354-40-AT (EUCTR) | 26/05/2010 | 26/04/2010 | Überprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem Parkinsonsyndrom | Überprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem Parkinsonsyndrom | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Madopar INN or Proposed INN: LEVODOPA INN or Proposed INN: BENSERAZIDE | Universitätsklinik für Neurologie Innsbruck | NULL | Not Recruiting | Female: yes Male: yes | 15 | Austria | |||
| 593 | EUCTR2010-019396-29-IT (EUCTR) | 18/05/2010 | 05/03/2012 | Levodopa and Pramipexole dministration modalities in patients affected by parkinson desease. | Levodopa Administration Modalities and Pramipexole in Parkinson's Disease (LAMP-PD study) A multicenter, randomized, four parallel groups, active-controlled, open-label study to evaluate the risk of dyskinesia in early PD. - LAMP-PD | Patients with idiopathic Parkinson's Disease.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: COMTAN INN or Proposed INN: Entacapone INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: STALEVO*100CPR 50/12,5/200MG INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor Trade Name: STALEVO*100CPR 100/25/200MG INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor | AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO-VITTORIO EMANUELE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 594 | JPRN-UMIN000003601 | 2010/05/01 | 18/05/2010 | Comparative study of ropinirole and entacapone for the treatment of wearing-off in advanced Parkinson's disease patients | Parkinson's disease | Increase dosage of ropinirole Addition of entacapone | Kansai Medical University | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 30 | Not selected | Japan | |
| 595 | EUCTR2009-018137-37-GB (EUCTR) | 14/04/2010 | 18/03/2010 | An open label, single site, 12 month, Phase II, randomised controlled trial evaluating the safety and efficacy of Exendin-4 (Exenatide) in the treatment of patients with moderate severity Parkinson's disease. - Exendin-4 as a treatment for Parkinson's disease- pilot trial | An open label, single site, 12 month, Phase II, randomised controlled trial evaluating the safety and efficacy of Exendin-4 (Exenatide) in the treatment of patients with moderate severity Parkinson's disease. - Exendin-4 as a treatment for Parkinson's disease- pilot trial | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | University College London | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 596 | JPRN-JapicCTI-101198 | 01/4/2010 | A double-blind confirmatory study for AD-810N (zonisamide) in patients with Parkinson's disease (Phase III) | A double-blind confirmatory study for AD-810N (zonisamide) in patients with Parkinson's disease (Phase III) | Parkinson's disease | Intervention name : Zonisamide Dosage And administration of the intervention : Oral Control intervention name : null | Dainippon Sumitomo Pharma Co., Ltd. | NULL | 20 | 74 | BOTH | 360 | Phase 3 | NULL | ||
| 597 | NCT01113320 (ClinicalTrials.gov) | April 2010 | 8/4/2010 | Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects | A Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesias | Parkinson's Disease | Drug: Placebo;Drug: Safinamide | Newron | NULL | Completed | 30 Years | N/A | Both | 26 | Phase 2 | Austria;Canada;France;Germany;South Africa |
| 598 | NCT00988117 (ClinicalTrials.gov) | April 2010 | 29/9/2009 | The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems | The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD) | Parkinsons Disease With Dementia;Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems | Drug: Rivastigmine Patch 9.5 cm2 | University of California, San Francisco | Novartis | Completed | 55 Years | N/A | All | 15 | Phase 4 | United States |
| 599 | EUCTR2009-017174-20-DE (EUCTR) | 15/03/2010 | 07/01/2010 | A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease. | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study | Idiopathic Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015E, EMD 1195686, MSC2191632B INN or Proposed INN: safinamide Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 24 | France;Canada;Austria;South Africa;Germany | |||
| 600 | NCT01503944 (ClinicalTrials.gov) | March 2010 | 14/7/2010 | A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET) | Detection of Striatal Dopaminergic Degeneration and Neocortical Amyloid Pathology in Patients With Dementia With Lewy Bodies, Alzheimer's Disease, Parkinson's Disease, and Healthy Elderly Volunteers | Dementia With Lewy Bodies;Alzheimer's Disease;Parkinson's Disease | Drug: 18F-AV-133;Drug: 18F-AV-45 | Avid Radiopharmaceuticals | NULL | Completed | 50 Years | N/A | Both | 30 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 601 | NCT01055379 (ClinicalTrials.gov) | March 2010 | 22/1/2010 | Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOn | A Randomised, Double-blind, Placebo-controlled Study to Evaluate if Rasagiline Can Improve Depressive Symptoms and Cognitive Function in Non-demented, Idiopathic Parkinson's Disease Patients: ACCORDO Study | Depressive Symptoms;Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Lundbeck Italia S.p.A. | Teva Pharmaceutical Industries | Completed | 40 Years | 80 Years | All | 121 | Phase 4 | Italy |
| 602 | NCT01092065 (ClinicalTrials.gov) | March 2010 | 22/3/2010 | Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia | A 6-week, Double-blind, Placebo-controlled, Randomized, Multicenter Study to Explore the Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With OFF Time and Moderate-severe L-dopa Induced Dyskinesia | Parkinson's Disease | Drug: AFQ056 with L-dopa;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 80 Years | All | 23 | Phase 2 | United States |
| 603 | EUCTR2009-017174-20-FR (EUCTR) | 24/02/2010 | 18/01/2010 | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. | Idiopathic Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 | Merck Serono S.A. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Germany;France;Austria | |||
| 604 | EUCTR2007-002963-28-DE (EUCTR) | 17/02/2010 | 22/12/2009 | A trial to determine the efficacy and safety of a low (50mg/day) and high dose (100mg / day) of safinamide, as add-on therapy, in patients with early Parkinson´s Disease treated with a sigle dopamin antagonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 605 | NCT01154166 (ClinicalTrials.gov) | February 15, 2010 | 29/6/2010 | A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa | A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa | Parkinson Disease | Drug: ReQuip PR;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 347 | Phase 3 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 606 | EUCTR2009-016360-37-SE (EUCTR) | 06/02/2010 | 04/12/2009 | TREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDY | TREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDY | Parkinsons disease is complicated by dyskinesias and dystonia. Due stabilizing properties, we believe (-)-OSU6162 may alleviate dyskinesias, without causing parkinsonism. Aim: To evaluate in a double-blind cross over pilot study whether OSU6162 attenuates dyskinesias without worsening parkinsonism in PD patients with motor complications using clinical examination and patient diaries. | Björn Holmberg | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Sweden | |||
| 607 | NCT01568047 (ClinicalTrials.gov) | February 2010 | 29/3/2012 | Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients | Multicentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations (Wearing-off Phenomenon) | Parkinson's Disease | Drug: Placebo;Drug: BIA 9-1067;Drug: Levodopa/Carbidopa;Drug: Levodopa/Benzerazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | N/A | All | 40 | Phase 2 | Romania;Ukraine |
| 608 | EUCTR2008-005492-94-BE (EUCTR) | 25/01/2010 | 12/08/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 609 | EUCTR2009-017416-33-DE (EUCTR) | 18/01/2010 | 21/12/2009 | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Male and female patients with Parkinson´s disease meeting UKPDS criteria MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 610 | EUCTR2008-005492-94-NL (EUCTR) | 18/01/2010 | 25/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients - | Idiopathic Parkinson's Disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1285 | Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 611 | NCT01007864 (ClinicalTrials.gov) | January 2010 | 3/11/2009 | Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine Agonists | Influence of the Non-Ergot Dopamine Agonist Piribedil on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Oral Non-Ergot Dopamine Agonists | Idiopathic Parkinson's Disease | Drug: piribedil;Drug: pramipexole or ropinirole | Desitin Arzneimittel GmbH | FGK Clinical Research GmbH | Completed | 35 Years | 80 Years | Both | 80 | Phase 3 | Germany |
| 612 | NCT01063621 (ClinicalTrials.gov) | January 2010 | 4/2/2010 | Extended Long-Term Safety Study of KW-6500 | Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection at Home in Patients With Parkinson's Disease) | Parkinson's Disease | Drug: KW-6500 | Kyowa Hakko Kirin Co., Ltd | NULL | Completed | 20 Years | N/A | All | 27 | Phase 3 | Japan |
| 613 | NCT01058291 (ClinicalTrials.gov) | January 2010 | 27/1/2010 | Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500 | Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease) | Parkinson's Disease | Drug: KW-6500;Drug: KW-6500 Placebo | Kyowa Hakko Kirin Co., Ltd | NULL | Completed | 20 Years | N/A | All | 31 | Phase 3 | Japan |
| 614 | EUCTR2008-005492-94-GB (EUCTR) | 09/12/2009 | 01/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | |||
| 615 | EUCTR2009-012897-12-RO (EUCTR) | 08/12/2009 | 30/03/2015 | A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor | A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor | Parkinson’s Disease MedDRA version: 17.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 | Product Name: BIA 9-1067 Product Code: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Restex Tabletten INN or Proposed INN: LEVODOPA INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE | BIAL-Portela & Ca, SA | NULL | Not Recruiting | Female: yes Male: yes | 32 | Romania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 616 | EUCTR2009-012419-16-DE (EUCTR) | 03/12/2009 | 20/10/2009 | Influence of the Non-Ergot Dopamine agonist Piribedil on vigilance and cognitive function in patients with Parkinson's disease compared to other oral Non-Ergot Dopamine agonists - PIVICOG-PD | Influence of the Non-Ergot Dopamine agonist Piribedil on vigilance and cognitive function in patients with Parkinson's disease compared to other oral Non-Ergot Dopamine agonists - PIVICOG-PD | idiopathic Parkinson's disease MedDRA version: 12.0;Level: PT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Clarium 50 mg Retardtabletten INN or Proposed INN: piribedil | Desitin Arzneimittel GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 617 | EUCTR2008-005492-94-FR (EUCTR) | 25/11/2009 | 01/10/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients - | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1285 | Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain | ||||
| 618 | EUCTR2008-005492-94-ES (EUCTR) | 23/11/2009 | 18/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson - | Idiopathic Parkinson's DiseaseEnfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1285 | Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain | ||||
| 619 | EUCTR2009-013004-31-IT (EUCTR) | 02/11/2009 | 02/11/2009 | Early combined prolonged release ropinirole and rasagiline therapy in newly diagnosed patients with Parkinsons disease. A prospective, randomized, parallel groups, long-term follow-up study including delayed-start design of rasagiline - Early combined ropinirole and rasagiline therapy in patients with Parkinsons disease | Early combined prolonged release ropinirole and rasagiline therapy in newly diagnosed patients with Parkinsons disease. A prospective, randomized, parallel groups, long-term follow-up study including delayed-start design of rasagiline - Early combined ropinirole and rasagiline therapy in patients with Parkinsons disease | Patients with Parkinson`s diesease MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | INN or Proposed INN: Rasagiline INN or Proposed INN: Ropinirole | UNIVERSITA` DEGLI STUDI DI PARMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 620 | NCT01023282 (ClinicalTrials.gov) | November 2009 | 1/12/2009 | Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients | Randomised, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ACR325 in Parkinson's Disease Patients, With Evaluation of the Effect on Levodopa Induced Dyskinesias as a Secondary Measure | Parkinson's Disease;Tolerability | Drug: ACR325;Drug: Placebo | NeuroSearch A/S | NULL | Completed | 30 Years | 75 Years | Both | 22 | Phase 1 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 621 | NCT01007630 (ClinicalTrials.gov) | November 2009 | 3/11/2009 | A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients | A Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | The Parkinson's Institute | Teva Neuroscience, Inc. | Active, not recruiting | N/A | 90 Years | Both | 36 | Phase 4 | United States |
| 622 | EUCTR2008-005492-94-HU (EUCTR) | 27/10/2009 | 22/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Portugal;Estonia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | |||
| 623 | EUCTR2008-004146-88-PL (EUCTR) | 19/10/2009 | 31/08/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy | ||
| 624 | EUCTR2008-005492-94-SK (EUCTR) | 14/10/2009 | 22/10/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 625 | EUCTR2008-005492-94-AT (EUCTR) | 02/10/2009 | 03/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 626 | EUCTR2008-005492-94-EE (EUCTR) | 01/10/2009 | 15/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 627 | NCT01631825 (ClinicalTrials.gov) | October 2009 | 25/6/2012 | A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients | An Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 321 | Phase 3 | Japan |
| 628 | NCT00957203 (ClinicalTrials.gov) | October 2009 | 7/8/2009 | Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients | Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3) | Parkinson's Disease | Drug: Istradefylline | Kyowa Hakko Kirin Company, Limited | NULL | Completed | 20 Years | N/A | Both | 308 | Phase 3 | Japan |
| 629 | NCT01016470 (ClinicalTrials.gov) | October 2009 | 28/9/2009 | Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s Disease | Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s Disease | Parkinson`s Disease | Dietary Supplement: VIUSID/ALZER;Dietary Supplement: Placebo | Catalysis SL | NULL | Completed | 20 Years | 90 Years | Both | 100 | Phase 3 | Cuba |
| 630 | NCT00986245 (ClinicalTrials.gov) | September 2009 | 24/9/2009 | Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily | An Open-label, Multi-center, Crossover Study to Compare the Effect of Once-daily Ropinirole PR and Twice-daily Ropinirole PR in Patients With Parkinson Disease | Parkinson Disease | Drug: Ropinirole Prolonged release | Seoul National University Hospital | NULL | Completed | 30 Years | 80 Years | All | 82 | Phase 4 | Korea, Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 631 | NCT00986414 (ClinicalTrials.gov) | September 2009 | 29/9/2009 | Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | Parkinson Disease;Dyskinesias | Drug: AFQ056;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 80 Years | All | 260 | Phase 2 | Australia;Canada;Finland;France;Germany;Italy;Japan;Spain |
| 632 | NCT00903838 (ClinicalTrials.gov) | September 2009 | 14/5/2009 | A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia. | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia. | Advanced Stage Parkinson's Disease | Drug: pardoprunox;Drug: pramipexole | Abbott Products | NULL | Terminated | 30 Years | N/A | Both | 37 | Phase 2 | Germany;Italy;Portugal |
| 633 | NCT00907972 (ClinicalTrials.gov) | September 2009 | 22/5/2009 | The Effects of Vitamin D and Bone Loss in Parkinson's Disease | Effect of Vitamin D3 Supplementation in Parkinson's Disease Patients - A Pilot Study | Parkinson Disease | Dietary Supplement: Vitamin D3;Other: Placebo | Memorial Medical Center | Department of Defense | Completed | 18 Years | N/A | Both | 23 | Phase 2 | United States |
| 634 | EUCTR2008-004146-88-BG (EUCTR) | 13/08/2009 | 13/07/2009 | An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 635 | EUCTR2008-008712-98-DE (EUCTR) | 07/08/2009 | 13/07/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 198 | France;Finland;Spain;Germany;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 636 | NCT03316365 (ClinicalTrials.gov) | August 2009 | 16/10/2017 | Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease | Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease | Continuous Rhythmic Auditory Stimulation;Intermittent Rhythmic Auditory Stimulation | Other: Rhythmic Auditory Stimulation (RAS) | University of Toronto | Poudre Valley Health System Fort Collins CO;Colorado State University | Completed | 18 Years | N/A | All | 60 | N/A | NULL |
| 637 | NCT01580787 (ClinicalTrials.gov) | August 2009 | 16/4/2012 | Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment | Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment | Parkinson´s Disease | Device: Balance Training with Nintendo Wii Fit;Other: Physical Therapy | Sao Camilo University Center | NULL | Completed | 65 Years | 85 Years | Both | 32 | N/A | NULL |
| 638 | EUCTR2008-004146-88-PT (EUCTR) | 31/07/2009 | 14/04/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 639 | EUCTR2009-011736-35-FR (EUCTR) | 27/07/2009 | 06/08/2009 | Etude pilote de phase II, N=1 en crossover répétés, en double aveugle, randomiséeversus placebo, multicentrique, évaluant l’efficacité de la SIMVAstatine sur lesDYSkinésies induites par la L-Dopa chez des patients atteints de maladie de Parkinson - SIMVADYS | Etude pilote de phase II, N=1 en crossover répétés, en double aveugle, randomiséeversus placebo, multicentrique, évaluant l’efficacité de la SIMVAstatine sur lesDYSkinésies induites par la L-Dopa chez des patients atteints de maladie de Parkinson - SIMVADYS | Maladie de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: LODALÈS® Product Code: simvastatine | CHU de Bordeaux | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | France | ||
| 640 | NCT00955318 (ClinicalTrials.gov) | July 2009 | 7/8/2009 | Long-Term Safety Study of KW-6500 in Patients With Parkinson's Disease | Phase 3 Study of KW-6500 (Safety Study for Long-Term Self-Administration at Home in Patients With Parkinson's Disease | Parkinson's Disease | Drug: KW-6500 | Kyowa Hakko Kirin Co., Ltd | NULL | Completed | 20 Years | N/A | All | 58 | Phase 3 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 641 | NCT00909545 (ClinicalTrials.gov) | July 2009 | 26/5/2009 | Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease | A Pilot Phase II Double-Blind, Placebo-Controlled, Tolerability and Dosage Finding Study of Isradipine CR as a Disease Modifying Agent in Patients With Early Parkinson Disease | Parkinson Disease | Drug: Isradipine CR 5mg;Drug: Isradipine CR 10mg;Drug: Isradipine CR 20mg;Drug: Placebo | Northwestern University | Michael J. Fox Foundation for Parkinson's Research;Northwestern University Dixon Fund;The Parkinson Study Group | Completed | 30 Years | N/A | All | 99 | Phase 2 | United States;Canada |
| 642 | NCT00955526 (ClinicalTrials.gov) | July 2009 | 7/8/2009 | Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3) | Parkinson's Disease | Drug: Istradefylline;Drug: Placebo | Kyowa Hakko Kirin Company, Limited | NULL | Completed | 20 Years | N/A | Both | 373 | Phase 3 | Japan |
| 643 | NCT00918177 (ClinicalTrials.gov) | July 2009 | 1/6/2009 | An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease | Dual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's Patients | Parkinson's Disease | Drug: AP09004;Drug: Carbidopa/Levodopa, immediate release | Intec Pharma Ltd. | NULL | Completed | 18 Years | N/A | Both | 72 | Phase 2 | Israel |
| 644 | NCT00955604 (ClinicalTrials.gov) | July 2009 | 6/8/2009 | Azilect + Antidepressant Chart Review | Investigation of the Occurrence of Serotonin Toxicity in Parkinson's Disease (PD) Patients Treated Concomitantly With Rasagiline and Antidepressants, Using Retrospective Chart Review | Serotonin Syndrome | Drug: Group R+AD Rasagiline + Antidepressant;Drug: Group R Rasagiline;Drug: Group AD Anti-PD + Antidepressant | Teva Pharmaceutical Industries | NULL | Completed | N/A | N/A | All | 1500 | N/A | United States |
| 645 | EUCTR2008-004146-88-ES (EUCTR) | 16/06/2009 | 16/04/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 498 | Phase 3 | Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 646 | EUCTR2008-008712-98-FR (EUCTR) | 10/06/2009 | 28/04/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | France;Finland;Spain;Germany;Italy | |||
| 647 | EUCTR2009-012529-12-FR (EUCTR) | 10/06/2009 | 18/05/2009 | A randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease - REQUIP | A randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease - REQUIP | parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: REQUIP-LP Product Name: ropinirole Trade Name: REQUIP Product Name: ropinirole | CHU de Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | France | |||
| 648 | EUCTR2008-004146-88-CZ (EUCTR) | 08/06/2009 | 07/04/2009 | An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 649 | NCT00921128 (ClinicalTrials.gov) | June 2, 2009 | 13/6/2009 | Convection-Enhanced Delivery to Study the Pathophysiology Underlying the Clinical Features of Parkinson s Disease | Convection Enhanced Delivery of Muscimol to Study the Pathophysiology Underlying the Clinical Features of Parkinson's Disease | Parkinson's Disease | Drug: Muscimol | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1 | United States |
| 650 | NCT01519856 (ClinicalTrials.gov) | June 2009 | 12/3/2010 | PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy | Efficacy and Safety of Long-term Therapy With Piribedil (CLARIUM) in Patients With M. Parkinson Under Consideration of Quality of Life Parameters and Cognitive Function | Parkinson's Disease | Drug: piribedil (Clarium) | Desitin Arzneimittel GmbH | NULL | Completed | 18 Years | N/A | Both | 908 | N/A | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 651 | NCT01628926 (ClinicalTrials.gov) | June 2009 | 24/6/2012 | A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients | A Double-Blind, 3-Arm, Parallel Group, Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa | Parkinson's Disease | Drug: SPM 962;Drug: Ropinirole;Drug: Placebo | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 420 | Phase 3 | Japan |
| 652 | EUCTR2008-004146-88-SK (EUCTR) | 25/05/2009 | 28/05/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 653 | EUCTR2008-004146-88-FI (EUCTR) | 19/05/2009 | 06/04/2009 | An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 654 | EUCTR2008-008712-98-FI (EUCTR) | 18/05/2009 | 08/04/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | moderate to severe levodopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 198 | Finland;Germany;France;Spain;Italy | |||
| 655 | EUCTR2008-008712-98-IT (EUCTR) | 14/05/2009 | 05/05/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease - ND | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease - ND | moderate to severe levodopa induced dyskinesia with Parkinson`s disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Code: AFQ056 Product Code: AFQ056 Product Code: AFQ056 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 234 | Finland;Germany;France;Spain;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 656 | EUCTR2008-000400-81-DE (EUCTR) | 11/05/2009 | 29/01/2009 | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | Advanced Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex Product Name: pramipexole INN or Proposed INN: pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate Trade Name: Mirapex Product Name: Pramipexole INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Portugal;Germany;Italy | |||
| 657 | EUCTR2007-002963-28-BG (EUCTR) | 03/05/2009 | 21/05/2009 | A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson’s Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 658 | NCT00902941 (ClinicalTrials.gov) | May 2009 | 13/5/2009 | Olfaction in Patients With Parkinson's Disease Following Treatment With Rasagiline | Reversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With Rasagiline | Parkinson´s Disease | Drug: Azilect 1mg;Drug: Placebo | Technische Universität Dresden | NULL | Completed | 18 Years | 64 Years | Both | 34 | Phase 4 | Germany |
| 659 | NCT00767546 (ClinicalTrials.gov) | May 2009 | 5/10/2008 | Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients | Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients | Parkinson Disease;Parkinsonism;Seborrheic Dermatitis | Drug: Botulinum toxin | Rabin Medical Center | NULL | Not yet recruiting | 18 Years | N/A | Both | 40 | Phase 1 | NULL |
| 660 | EUCTR2008-005492-94-IT (EUCTR) | 30/04/2009 | 15/04/2009 | OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND | IDIOPATHIC PARKINSON`S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: SAFINAMIDE Product Code: NW-1015 Product Name: SAFINAMIDE Product Code: NW-1015 | MERCK SERONO SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 661 | NCT00845000 (ClinicalTrials.gov) | April 21, 2009 | 13/2/2009 | Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550) | Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated Patients | Parkinson Disease | Drug: SCH 420814 10 mg;Drug: SCH 420814 100 mg;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa | Merck Sharp & Dohme Corp. | Oregon Health and Science University | Completed | 18 Years | N/A | All | 12 | Phase 1 | United States |
| 662 | EUCTR2008-008210-38-FR (EUCTR) | 16/04/2009 | 19/03/2009 | Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-I | Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-I | Patients ayant une maladie de Parkinson Patients à un stade évolué de la maladie avec des troubles de la marche sévères MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease MedDRA version: 9.1;Level: PT;Term: Parkinson's disease | Trade Name: EBIXA® Product Name: mémantine Trade Name: L-Dopa/ MODOPAR Product Name: L-Dopa | Chru de Lille | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | France | |||
| 663 | EUCTR2007-004234-16-AT (EUCTR) | 14/04/2009 | 10/03/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 664 | EUCTR2007-001095-36-SK (EUCTR) | 09/04/2009 | 09/04/2008 | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 625 | Phase 3 | Hungary;Slovakia | ||
| 665 | EUCTR2008-005085-30-DE (EUCTR) | 06/04/2009 | 04/03/2009 | Reversibility of olfactory loss in patients with Idiopathic Parkinson’s disease following treatment with Rasagiline | Einfluss von Rasagilin auf das Riechvermögen von Patienten mit idiopathischem Parkinson-Syndrom(Reversibility of olfactory loss in patients with Idiopathic Parkinson’s disease following treatment with Rasagiline) - Olfaction | Idiopathic Parkinson syndrome (IPS), State according to Hoehn & Yahr: maximum III MedDRA version: 13.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Azilect INN or Proposed INN: Rasagilin | Technische Universität Dresden | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 666 | EUCTR2008-000400-81-PT (EUCTR) | 03/04/2009 | 27/01/2009 | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | Advanced Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex Product Name: pramipexole INN or Proposed INN: pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate Trade Name: Mirapex Product Name: Pramipexole INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate | Solvay Pharmaceuticals BV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Portugal;Germany;Italy | |||
| 667 | EUCTR2007-002963-28-PL (EUCTR) | 02/04/2009 | 27/02/2009 | A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as an add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy | ||
| 668 | EUCTR2007-002964-90-AT (EUCTR) | 02/04/2009 | 13/02/2008 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 669 | EUCTR2007-004235-37-AT (EUCTR) | 02/04/2009 | 10/03/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 670 | JPRN-UMIN000001841 | 2009/04/01 | 02/04/2009 | A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with Parkinson disease aged between 45 and 85 years old to improve neurological signs and quality of life | Parkinson disease | Vitamin D3 placebo | Jikei University School of Medicine | NULL | Complete: follow-up complete | 45years-old | 85years-old | Male and Female | 120 | Not selected | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 671 | NCT00875316 (ClinicalTrials.gov) | April 2009 | 2/4/2009 | Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients | A Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One Month | Parkinson's Disease | Drug: Cogane™ (PYM50028) | Phytopharm | NULL | Completed | 40 Years | 80 Years | Both | 36 | Phase 1 | United Kingdom |
| 672 | NCT01568034 (ClinicalTrials.gov) | April 2009 | 29/3/2012 | A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 | A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor | Parkinson's Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: Levodopa/Carbidopa;Drug: Levodopa/Benzerazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | 75 Years | All | 10 | Phase 2 | Portugal;Romania;Ukraine |
| 673 | NCT00914134 (ClinicalTrials.gov) | April 2009 | 1/6/2009 | Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease | Effect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Levodopa infusion | Helsinki University | Solvay Pharmaceuticals | Completed | 40 Years | 80 Years | Both | 12 | Phase 4 | Finland |
| 674 | NCT00865579 (ClinicalTrials.gov) | April 2009 | 10/3/2009 | Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients | Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients | Parkinson's Disease | Drug: Safinamide | Newron | NULL | Terminated | 30 Years | N/A | All | 964 | Phase 3 | Romania |
| 675 | EUCTR2008-000400-81-IT (EUCTR) | 31/03/2009 | 17/04/2009 | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson?s Disease Experiencing Motor Fluctuations and Dyskinesia - ND | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson?s Disease Experiencing Motor Fluctuations and Dyskinesia - ND | Advanced Parkinson`s Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Trade Name: Mirapex INN or Proposed INN: Pramipexole Trade Name: Mirapex INN or Proposed INN: Pramipexole Trade Name: Mirapex INN or Proposed INN: Pramipexole | SOLVAY PHARMACEUTICALS B.V. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Portugal;Germany;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 676 | EUCTR2008-004447-11-GB (EUCTR) | 27/03/2009 | 07/01/2009 | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: | Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2b | Germany;United Kingdom;Italy | ||
| 677 | NCT00866502 (ClinicalTrials.gov) | March 2009 | 18/3/2009 | A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease | A Randomized, Double-blind, Placebo Controlled, Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Using an Implanted Catheter and a SynchroMed® II Pump. | Parkinson's Disease | Drug: sNN0031;Drug: Placebo | Newron Sweden AB | Medtronic;Quintiles | Completed | 30 Years | 75 Years | Both | 12 | Phase 1;Phase 2 | Sweden |
| 678 | NCT00940914 (ClinicalTrials.gov) | March 2009 | 16/7/2009 | Dopaminergic Loss and Pain in Parkinson's Disease | Evaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without Pain | Parkinson's Disease;Pain | Drug: ioflupane 123I (DATSCAN®) | University Hospital, Toulouse | NULL | Completed | 30 Years | 70 Years | All | 20 | Phase 2 | France |
| 679 | NCT00888004 (ClinicalTrials.gov) | March 2009 | 23/4/2009 | Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients | A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy and Tolerability of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Severe L-dopa Induced Dyskinesias | Parkinson's Disease;L-dopa Induced Dyskinesia | Drug: AFQ056;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 85 Years | Both | 28 | Phase 2 | Germany |
| 680 | EUCTR2008-006278-13-NL (EUCTR) | 04/02/2009 | 15/10/2008 | Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations. | Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations. | patients with advanced (>5 years) Parkinson's disease and visual hallucinations. MedDRA version: 9.1;Level: LLT;Classification code 10047570;Term: Visual hallucinations MedDRA version: 9.1;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Reminyl Retard Trade Name: Sinemet 125 mg | UMCG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Netherlands | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 681 | NCT00806468 (ClinicalTrials.gov) | February 2009 | 9/12/2008 | Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease | A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease | Parkinson Disease | Drug: Desmotabs | Johannes Gutenberg University Mainz | NULL | Terminated | 18 Years | 85 Years | Male | 1 | Phase 4 | Germany |
| 682 | NCT00873392 (ClinicalTrials.gov) | February 2009 | 31/3/2009 | Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease | Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease(One Daily Administration).A Controlled Randomised Study, in Two Parallel Groups and Single Blind in 40 Patients. | Idiopathic Parkinson's Disease | Drug: Transdermal nicotine;Other: Usual drug treatment of Parkinson's disease | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 35 Years | 70 Years | Both | 40 | Phase 2 | France |
| 683 | EUCTR2007-007853-30-SE (EUCTR) | 28/01/2009 | 21/12/2007 | A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate severity, using an implanted catheter and a SynchroMed® II pump. | A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate severity, using an implanted catheter and a SynchroMed® II pump. | Idiopathic Parkinson's disease (PD) of moderate severity (modified Hoehn & Yahr Stage IIb - III) | Product Name: sNN0031 Product Code: sNN0031 | NeuroNova AB | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
| 684 | EUCTR2007-002963-28-CZ (EUCTR) | 19/01/2009 | 30/10/2007 | A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 685 | EUCTR2007-003035-22-PT (EUCTR) | 09/01/2009 | 01/07/2008 | A safety and tolerability study of ACP-103 in patients with Parkinson's Disease Psychosis | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | MedDRA version: 18.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | ACADIA Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 686 | EUCTR2008-004906-15-FR (EUCTR) | 05/01/2009 | 16/03/2009 | EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson | EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson | Maladie de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DATSCAN | CHU Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 687 | NCT00857532 (ClinicalTrials.gov) | January 2009 | 5/3/2009 | Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients | A Phase 2 Trial of Florbetapir F18 PET Imaging of ß-amyloid in Parkinson's Disease Patients With Cognitive Impairment | Parkinson's Disease | Drug: florbetapir F 18 | Avid Radiopharmaceuticals | National Institutes of Health (NIH);National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 60 Years | N/A | All | 31 | Phase 2 | United States |
| 688 | EUCTR2004-000148-26-AT (EUCTR) | 31/12/2008 | 26/11/2008 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Hungary;Finland;Spain;Austria;Italy;Sweden | ||
| 689 | EUCTR2008-003966-25-DE (EUCTR) | 23/12/2008 | 04/11/2008 | Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA | Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA | Effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10064016;Term: Nocturnal polyuria MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease | Trade Name: Desmotabs® 0,2 mg Tabletten Product Name: Desmotabs® 0,2mg Tabletten INN or Proposed INN: Desmopressin Acetat | Universität Mainz, Klinik und Poliklinik für Neurologie | NULL | Not Recruiting | Female: no Male: yes | 20 | Germany | |||
| 690 | NCT00809302 (ClinicalTrials.gov) | December 2008 | 15/12/2008 | Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg Twice Daily) in Patients With Early Parkinson Disease (APLIED) | Early Parkinson Disease | Drug: aplindore MR tablets or Placebo | Neurogen Corporation | NULL | Terminated | 30 Years | N/A | Both | 9 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 691 | EUCTR2008-004943-12-SK (EUCTR) | 24/11/2008 | 10/10/2008 | The Rubens Study:A Multicenter, Randomized, Double-blind, Parallel Group, Placebo and Pramipexole Controlled Study to Explore the Efficacy, Tolerability and Safety of Different Doses and Titration Schedules of Pardoprunox Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rubens Study | The Rubens Study:A Multicenter, Randomized, Double-blind, Parallel Group, Placebo and Pramipexole Controlled Study to Explore the Efficacy, Tolerability and Safety of Different Doses and Titration Schedules of Pardoprunox Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rubens Study | Early Stage Parkinson’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate | Solvay Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Slovakia | ||
| 692 | EUCTR2007-003035-22-GB (EUCTR) | 05/11/2008 | 20/12/2007 | A safety and tolerability study of ACP-103 in patients with Parkinson's Disease Psychosis | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease - ACP-103-015 | Psychosis in Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | ACADIA Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden | |||
| 693 | EUCTR2007-004890-24-PT (EUCTR) | 07/10/2008 | 25/06/2008 | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy | Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets Product Code: JP-1730/F01 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets Product Code: JP-1730/F02 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets Product Code: JP-1730/F03 INN or Proposed INN: Fipamezole hydrochloride | Juvantia Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Portugal;France | ||
| 694 | EUCTR2008-003869-72-PT (EUCTR) | 03/10/2008 | 25/06/2008 | A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR | A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR | Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Code: BIA 9-1067 | Bial - Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Portugal | |||
| 695 | EUCTR2007-004235-37-IT (EUCTR) | 02/10/2008 | 28/11/2007 | Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND | Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND | Patients with advanced idiopathic PD MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 696 | EUCTR2007-000350-31-IT (EUCTR) | 02/10/2008 | 11/02/2008 | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND | mild to moderately severe dementia associated with Parkinson?s disease (PDD) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Exelon path transdermal Product Code: ENA713B INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Product Name: Exelon path transdermal Product Code: ENA713B INN or Proposed INN: Rivastigmine | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 550 | France;Spain;Italy | |||
| 697 | NCT00906828 (ClinicalTrials.gov) | October 2008 | 19/5/2009 | Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors | Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors | Parkinson Disease | Drug: levodopa/carbidopa;Drug: entacapone;Drug: tolcapone | Uppsala University | Swedish Parkinson's Disease Foundation;Swedish Society for Medical Research | Completed | 30 Years | 90 Years | Both | 10 | Phase 4 | Sweden |
| 698 | NCT00758849 (ClinicalTrials.gov) | September 2008 | 24/9/2008 | Fipamezole in Neurogenic Orthostatic Hypotension | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients With Multiple System Atrophy or Parkinson's Disease | Symptomatic Neurogenic Orthostatic Hypotension (NOH);Parkinson's Disease;Multiple System Atrophy | Drug: Placebo;Drug: Fipamezole | Juvantia Pharma Ltd | Santhera Pharmaceuticals | Not yet recruiting | 30 Years | 80 Years | Both | 24 | Phase 2 | France;Portugal |
| 699 | NCT00755027 (ClinicalTrials.gov) | September 2008 | 17/9/2008 | Rasagiline and Apathy in Parkinson's Disease | A Randomised Placebo-controlled Trial of Rasagiline in Parkinson Disease Patients With Symptoms of Apathy | Parkinson's Disease | Drug: Rasagiline | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | NULL | Completed | 18 Years | 80 Years | Both | 40 | Phase 4 | Spain |
| 700 | EUCTR2007-004235-37-GB (EUCTR) | 19/08/2008 | 26/11/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 701 | EUCTR2004-005234-39-DE (EUCTR) | 11/08/2008 | 02/12/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;United Kingdom;Germany;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 702 | NCT00601978 (ClinicalTrials.gov) | August 2008 | 11/1/2008 | Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing Off | Parkinson's Disease | Drug: carbidopa/levodopa;Drug: Carbidopa/Levodopa/Entacapone | Novartis Pharmaceuticals | NULL | Withdrawn | 45 Years | 75 Years | Both | 0 | Phase 4 | United States |
| 703 | EUCTR2004-000148-26-HU (EUCTR) | 26/07/2008 | 19/07/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Finland;Hungary;Czech Republic;Spain;Italy;Sweden | ||
| 704 | EUCTR2008-003581-26-SE (EUCTR) | 18/07/2008 | 30/05/2008 | Pharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMT | Pharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMT | Parkinson's disease (G20.9), advanced, patients presently on Duodopa treatment. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Duodopa INN or Proposed INN: levodopa INN or Proposed INN: carbidopa Trade Name: Comtess INN or Proposed INN: entacapone Trade Name: Tasmar INN or Proposed INN: tolcapone | Dept of Neuroscience, Uppsala University | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Sweden | ||||
| 705 | EUCTR2008-001336-13-FR (EUCTR) | 16/07/2008 | 09/06/2008 | Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2 | Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2 | Maladie Parkinson MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Nicorette 5 mg/ 16 h Product Name: Nicorette 5 mg/ 16 h INN or Proposed INN: Nicotine Product Name: Nicorette 10mg/ 16 h INN or Proposed INN: Nicotine Product Name: Nicorette 15 mg/ 16 h INN or Proposed INN: Nicotine | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 706 | EUCTR2007-003134-42-DE (EUCTR) | 19/06/2008 | 20/02/2008 | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. | Idiopathic Parkinson’s disease and end-of-dose wearing off. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo 100 mg/ 25 mg/ 200 mg Filmtabletten Product Name: Stalevo INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONE Trade Name: Nacom 100 Product Name: Nacom INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany | |||
| 707 | NCT00822913 (ClinicalTrials.gov) | June 2008 | 14/1/2009 | Botulinum A Toxin in Patients With Parkinson's Disease | The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity. | Parkinson's Disease;Multiple System Atrophy;Detrusor Overactivity | Drug: Intravesical injection of Botulinum A toxin | University Of Perugia | University of Roma La Sapienza | Enrolling by invitation | 18 Years | 80 Years | Both | 20 | Phase 4 | NULL |
| 708 | EUCTR2007-004235-37-PL (EUCTR) | 29/05/2008 | 16/04/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Austria;Poland;Sweden | |||
| 709 | EUCTR2007-004009-93-IT (EUCTR) | 20/05/2008 | 14/07/2008 | Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopram | Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopram | Depression, anxiety and ICD MedDRA version: 14.1;Level: SOC;Classification code 10037175;Term: Psychiatric disorders;System Organ Class: 10037175 - Psychiatric disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: CIPRALEX INN or Proposed INN: Escitalopram Trade Name: CIPRALEX INN or Proposed INN: Escitalopram | LUNDBECK ITALIA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 710 | EUCTR2007-004890-24-FR (EUCTR) | 07/05/2008 | 09/05/2008 | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy | Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets Product Code: JP-1730/F01 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets Product Code: JP-1730/F02 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets Product Code: JP-1730/F03 INN or Proposed INN: Fipamezole hydrochloride | Juvantia Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Portugal;France | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 711 | EUCTR2006-006752-35-DE (EUCTR) | 06/05/2008 | 23/03/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVER | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3B | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 712 | NCT01416818 (ClinicalTrials.gov) | May 2008 | 11/8/2011 | Treatment of Depression in Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled Study of Xiaoyao Pill Treatment of Depression in Patients With Parkinson's Disease | Depression in Parkinson's Disease | Drug: Xiaoyao Pill;Drug: Bupleurum+Ginkgo;Drug: placebo | Xuanwu Hospital, Beijing | NULL | Recruiting | 30 Years | 80 Years | Both | 60 | Phase 2 | China |
| 713 | EUCTR2007-004235-37-SE (EUCTR) | 23/04/2008 | 25/03/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 714 | EUCTR2007-004234-16-FI (EUCTR) | 16/04/2008 | 12/02/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 520 | Hungary;Finland;Czech Republic;Netherlands;France;Austria | |||
| 715 | EUCTR2007-001096-10-SK (EUCTR) | 11/04/2008 | 09/04/2008 | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study | advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Slovakia | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 716 | NCT00605553 (ClinicalTrials.gov) | April 2008 | 15/1/2008 | Study to Evaluate SYN115 in Parkinson's Disease | A Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: Tozadenant | Biotie Therapies Inc. | NULL | Completed | 40 Years | 75 Years | All | 30 | Phase 2 | United States |
| 717 | NCT00753636 (ClinicalTrials.gov) | April 2008 | 13/9/2008 | Parkinson's Disease Isradipine Safety Study | Phase II Safety and Tolerability of Isradipine (A Potential Neuroprotective Agent) in Patients With Parkinson's Disease- Stage II | Parkinson's Disease | Drug: Dynacirc CR (Isradipine) | Northwestern University | Northwestern Memorial Hospital | Completed | 30 Years | 75 Years | All | 31 | Phase 2 | United States |
| 718 | EUCTR2007-001095-36-HU (EUCTR) | 27/03/2008 | 06/02/2008 | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 625 | Hungary | |||
| 719 | EUCTR2007-005033-11-DE (EUCTR) | 27/03/2008 | 04/01/2008 | A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease | A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease | Patients with Parkinson's Disease | Product Name: Levodopa-Carbidopa Multilayer Extended Release Tablet Product Code: Levodopa-Carbidopa XL tablet (M) INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet® CR Product Name: Sinemet CR INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | CombinatoRx, Inc | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 720 | EUCTR2007-001096-10-HU (EUCTR) | 27/03/2008 | 15/02/2008 | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study | advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 500 | Hungary | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 721 | EUCTR2007-004234-16-HU (EUCTR) | 17/03/2008 | 17/01/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 722 | EUCTR2007-004235-37-HU (EUCTR) | 17/03/2008 | 17/01/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 723 | NCT00761137 (ClinicalTrials.gov) | March 2008 | 25/9/2008 | Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients | A Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Symptoms in Parkinson's Disease Patients | Sialorrhea Secondary to Parkinson's Disease | Drug: 0.3 mg tropicamide;Drug: 1 mg tropicamide;Drug: 3 mg tropicamide;Drug: 0 mg tropicamide | NeuroHealing Pharmaceuticals Inc. | Michael J. Fox Foundation for Parkinson's Research | Completed | 50 Years | 80 Years | All | 19 | Phase 2 | Argentina |
| 724 | NCT00642356 (ClinicalTrials.gov) | March 2008 | 19/3/2008 | Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off | An 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off | Parkinson's Disease | Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa | Novartis | NULL | Terminated | 30 Years | 85 Years | All | 14 | Phase 4 | United States |
| 725 | NCT00727727 (ClinicalTrials.gov) | March 2008 | 31/7/2008 | SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K) | Stabilization on, or Change-Over to the Non-Ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Private Practices. | Parkinson's Disease | Drug: Piribedil | Desitin Arzneimittel GmbH | NULL | Completed | 18 Years | N/A | Both | 750 | N/A | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 726 | NCT00658567 (ClinicalTrials.gov) | March 2008 | 10/4/2008 | A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis | Parkinson's Disease Psychosis | Drug: Pimavanserin tartrate (ACP-103) | ACADIA Pharmaceuticals Inc. | NULL | Completed | 40 Years | N/A | All | 123 | Phase 3 | United States;Austria;Belgium;Italy;Poland;Portugal;Serbia;Spain;Sweden | |
| 727 | NCT00607451 (ClinicalTrials.gov) | March 2008 | 22/1/2008 | Safety, Tolerability, PK and PD Study of Neu-120 in the Treatment of Levodopa-induced Dyskinesia | A Double-blind, Placebo Controlled, Crossover, Ascending Single Dose Safety Tolerability, Pharmacokinetic and Pharmacodynamic Study of Neu-120 in Patients With Advanced Phase Idiopathic Parkinson's Disease With Levodopa Induced Dyskinesia | Levodopa-induced Dyskinesia | Drug: Neu-120 | Neurim Pharmaceuticals Ltd. | NULL | Terminated | 30 Years | 80 Years | All | 8 | Phase 1;Phase 2 | Israel |
| 728 | EUCTR2007-000350-31-ES (EUCTR) | 13/02/2008 | 21/12/2007 | Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP) | Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP) | Demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP). MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon 4.6 mg/24 h transdermal patch INN or Proposed INN: rivastigmine Trade Name: Exelon 9.5 mg/24 h transdermal patch INN or Proposed INN: rivastigmine | Novartis Farmacéutica S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | France;Spain;Italy | |||
| 729 | EUCTR2007-002964-90-EE (EUCTR) | 13/02/2008 | 02/01/2008 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 730 | EUCTR2007-002195-34-FR (EUCTR) | 04/02/2008 | 07/12/2007 | Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups. | Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups. | Fatigue symptoms in Parkinson's disease. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | PIERRE FABRE MEDICAMENT | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 731 | NCT00624741 (ClinicalTrials.gov) | February 2008 | 15/2/2008 | Compassionate Use Study of Pergolide in Patients With Parkinson's Disease | Compassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's Disease | Parkinson Disease | Drug: Pergolide | Valeant Pharmaceuticals International, Inc. | NULL | No longer available | N/A | N/A | Both | N/A | NULL | |
| 732 | NCT02236728 (ClinicalTrials.gov) | February 2008 | 10/9/2014 | Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole | Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP) | Parkinson Disease | Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 497 | N/A | NULL |
| 733 | EUCTR2007-002467-27-GB (EUCTR) | 24/01/2008 | 26/11/2007 | Antidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramate | Antidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramate | Patients with idiopathic Parkinson's disease and levodopa-induced dyskinesias MedDRA version: 13.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 13.1;Classification code 10061536;Term: Parkinson's disease;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders | Product Name: Topiramate INN or Proposed INN: TOPIRAMATE | Salford Royal NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 734 | EUCTR2007-004235-37-ES (EUCTR) | 24/01/2008 | 08/03/2010 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 735 | EUCTR2007-000350-31-FR (EUCTR) | 22/01/2008 | 25/10/2007 | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD). | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD). | Mild to moderately severe dementia associated with Parkinson’s disease (PDD). MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon 4.6 mg/24 h transdermal patch INN or Proposed INN: rivastigmine Trade Name: Exelon 9.5 mg/24 h transdermal patch INN or Proposed INN: rivastigmine | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 550 | France;Spain;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 736 | EUCTR2007-004235-37-CZ (EUCTR) | 21/01/2008 | 18/12/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;United Kingdom;Czech Republic;Spain;Italy;Poland;Austria;Sweden | |||
| 737 | EUCTR2007-004234-16-CZ (EUCTR) | 21/01/2008 | 18/12/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 738 | EUCTR2007-004234-16-SK (EUCTR) | 14/01/2008 | 18/04/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands | ||
| 739 | EUCTR2007-004235-37-SK (EUCTR) | 14/01/2008 | 16/04/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden | ||
| 740 | EUCTR2007-004234-16-FR (EUCTR) | 11/01/2008 | 19/11/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | BOEHRINGER INGELHEIM | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 741 | NCT00600093 (ClinicalTrials.gov) | January 2008 | 13/1/2008 | Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine | Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine | Parkinson Disease;Perioperative Care | Drug: Amantadine | Rabin Medical Center | NULL | Terminated | N/A | N/A | Both | 20 | Phase 2 | Israel |
| 742 | NCT00562198 (ClinicalTrials.gov) | January 2008 | 19/11/2007 | PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding | Effects of Single Doses of Stalevo 200 and Levodopa/Carbidopa 200/50mg on Striatal 11C-Raclopride Binding Potential in Parkinson's Disease Patients With Wearing-Off Symptoms;an Open, Randomised, Active-Controlled,Two-Period Crossover Study. | Parkinson´s Disease | Drug: entacapone and carbidopa;Drug: Sinemet 200mg/50mg | Orion Corporation, Orion Pharma | NULL | Terminated | 45 Years | 80 Years | Both | 16 | Phase 2 | Finland |
| 743 | NCT00601523 (ClinicalTrials.gov) | January 2008 | 15/1/2008 | Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD). | Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD). | Parkinson Disease | Drug: Placebo;Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 511 | Phase 3 | United States;Austria;Czech Republic;Finland;France;Germany;Hungary;India;Japan;Malaysia;Netherlands;Russian Federation;Slovakia;Taiwan;Ukraine;Argentina |
| 744 | NCT00664209 (ClinicalTrials.gov) | January 2008 | 21/4/2008 | Treating H. Pylori in Parkinson's Patients With Motor Fluctuations | Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease | Parkinson's Disease;Helicobacter Infections;Motor Fluctuations | Drug: clartihromycin, amoxicillin, and omeprazole;Drug: placebo | University of California, Los Angeles | Michael J. Fox Foundation for Parkinson's Research | Terminated | N/A | N/A | Male | 64 | Phase 3 | United States |
| 745 | NCT01628965 (ClinicalTrials.gov) | January 2008 | 25/6/2012 | A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients | An Open-label Long-term Extension Trial From Phase II/III of SPM962 (243-07-001) in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 143 | Phase 2;Phase 3 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 746 | NCT00627588 (ClinicalTrials.gov) | January 2008 | 31/1/2008 | Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin for the Treatment of Bilateral Idiopathic Parkinson's Disease | A Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin®, Administered Using Stereotactic Injection to the Striatum of Patients With Bilateral, Idiopathic Parkinson's Disease. | Parkinson's Disease | Biological: ProSavin | Oxford BioMedica | NULL | Completed | 48 Years | 65 Years | Both | 15 | Phase 1;Phase 2 | France;United Kingdom |
| 747 | NCT00623103 (ClinicalTrials.gov) | January 2008 | 14/2/2008 | Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD) | A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD) | Parkinson's Disease Dementia | Drug: Rivastigmine capsule;Drug: Rivastigmine transdermal patch | Novartis | NULL | Completed | 50 Years | 85 Years | All | 583 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Turkey;United Kingdom |
| 748 | NCT00725478 (ClinicalTrials.gov) | January 2008 | 28/7/2008 | SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease | Stabilization on, or Change-over to the Non-ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Parkinson Clinic Ambulances and Larger Private Practices. | Parkinson's Disease | Drug: Piribedil | Desitin Arzneimittel GmbH | NULL | Completed | 18 Years | N/A | Both | 250 | N/A | NULL |
| 749 | NCT00623324 (ClinicalTrials.gov) | January 2008 | 14/2/2008 | The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's Disease | A Phase II, Dose Ranging, Randomized, Double Blind, Placebo-controlled, Multi-center, Pilot Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of Aplindore in Patients With Early Stage Parkinson's Disease | Early Stage Parkinson's Disease | Drug: Aplindore;Drug: Placebo | Ligand Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 40 | Phase 2 | United States |
| 750 | EUCTR2007-004654-81-GB (EUCTR) | 20/12/2007 | 16/10/2007 | A phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patients | A phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patients | Sialorrhoea associated with Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10059812;Term: Sialorrhoea | Trade Name: Catapres ampoules INN or Proposed INN: Clonidine hydrochloride Trade Name: Ditropan elixir INN or Proposed INN: Oxybutynin hydrochloride | Summit (Cambridge) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | Phase 2a | United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 751 | EUCTR2006-006907-35-IT (EUCTR) | 19/12/2007 | 20/04/2007 | A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER | A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER | Patient with Idiopathic Parkinson Diesease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: rotigotine INN or Proposed INN: rotigotine | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3b | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | ||
| 752 | EUCTR2004-000185-12-GB (EUCTR) | 13/12/2007 | 11/02/2005 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 740 | Phase 3 | Finland;Austria;Italy;United Kingdom;Sweden | |||
| 753 | EUCTR2007-002963-28-FI (EUCTR) | 12/12/2007 | 18/10/2007 | A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;South Africa;Germany | ||
| 754 | NCT00577460 (ClinicalTrials.gov) | December 2007 | 19/12/2007 | Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD | Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD) | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 32 Years | N/A | All | 391 | Phase 3 | Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom |
| 755 | EUCTR2007-002496-14-FI (EUCTR) | 05/11/2007 | 14/09/2007 | Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study. | Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study. | Parkinson’s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Stalevo® INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet® INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Product Name: 11C-Raclopride Other descriptive name: 11C-Raclopride | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | Finland | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 756 | NCT00560508 (ClinicalTrials.gov) | November 2007 | 16/11/2007 | A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period | A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ER | Parkinson Disease | Drug: Pramipexole Immediate Release;Drug: Pramipexole Extended Release | Boehringer Ingelheim | NULL | Completed | 1 Year | N/A | All | 112 | Phase 2;Phase 3 | Japan |
| 757 | NCT00610103 (ClinicalTrials.gov) | November 2007 | 22/1/2008 | Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa Therapy | A Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's Disease | Parkinson's Disease | Drug: apomorphine hydrochloride | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 16 | Phase 2 | Japan |
| 758 | NCT00558337 (ClinicalTrials.gov) | November 2007 | 12/11/2007 | Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's Disease | An Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease Patients | Parkinson's Disease | Drug: levodopa-carbidopa | Osmotica Pharmaceutical Corp. | NULL | Completed | 30 Years | 80 Years | Both | 78 | Phase 2 | Argentina |
| 759 | NCT01301651 (ClinicalTrials.gov) | November 2007 | 18/2/2011 | Effects of Virtual Reality Training in Patients With Parkinson's Disease | Effects of Virtual Reality Augmented Balance Training for Postural Control in Patients With Parkinson's Disease | Parkinson's Disease | Behavioral: balance training | National Taiwan University Hospital | National Science Council, Taiwan | Completed | 50 Years | 80 Years | Both | 42 | Phase 1 | Taiwan |
| 760 | EUCTR2007-004234-16-NL (EUCTR) | 29/10/2007 | 17/10/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 761 | EUCTR2007-001717-42-FR (EUCTR) | 25/10/2007 | 11/09/2007 | A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A | A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A | Patients with Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias | Product Name: SCH 420814 Product Code: N/A | Schering Plough Research Institute | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | France;Spain | ||
| 762 | EUCTR2007-003353-90-NL (EUCTR) | 23/10/2007 | 07/08/2007 | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Pramipexole Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 145 | Germany;Netherlands;France | |||
| 763 | EUCTR2007-003353-90-FR (EUCTR) | 17/10/2007 | 27/08/2007 | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Pramipexole Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | BOEHRINGER INGELHEIM | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 145 | Germany;Netherlands;France | |||
| 764 | EUCTR2006-006907-35-GB (EUCTR) | 09/10/2007 | 26/04/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH, UCB Group | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 765 | EUCTR2005-005791-32-SE (EUCTR) | 04/10/2007 | 30/07/2007 | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney. MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes) | Product Name: HF0220 Product Code: HF0220 Other descriptive name: 7-beta-hydroxyepiandrosterone | Hunter-Fleming Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 766 | EUCTR2007-002900-16-DE (EUCTR) | 01/10/2007 | 21/08/2007 | A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration study in patients with Parkinson’s disease to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias, and the safety and tolerability of AFQ056 in combination with L-dopa | A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration study in patients with Parkinson’s disease to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias, and the safety and tolerability of AFQ056 in combination with L-dopa | The main objective of this study is to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias. | Product Code: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 34 | Germany | |||
| 767 | NCT00642928 (ClinicalTrials.gov) | October 2007 | 21/3/2008 | Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients | Randomized, Dose-finding Study of BF 2.649 5, 10 20 and 40 mg/d in Comparison to Placebo in Excessive Daytime Sleepiness in Parkinson's Disease Patients (PD) | Excessive Daytime Sleepiness;Parkinson's Disease | Drug: Placebo;Drug: BF 2.649 5 mg;Drug: BF 2.649 10 mg;Drug: BF 2.649 20 mg;Drug: BF 2.649 40 mg | Bioprojet | NULL | Completed | 18 Years | N/A | Both | 108 | Phase 2 | France |
| 768 | NCT00582673 (ClinicalTrials.gov) | October 2007 | 21/12/2007 | Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa | A Multi-centre, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multiple Oral Dose Titration Study in Patients With Parkinson's Disease to Assess the Efficacy of AFQ056 in Reducing L-dopa Induced Dyskinesias, and the Safety and Tolerability of AFQ056 in Combination With L-dopa | Parkinson's Disease | Drug: AFQ056;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 85 Years | Both | 31 | Phase 2 | Germany |
| 769 | NCT00566462 (ClinicalTrials.gov) | October 2007 | 29/11/2007 | Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT | Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT | Parkinson's Disease | Drug: perampanel;Drug: placebo | Eisai Inc. | NULL | Terminated | 30 Years | N/A | All | 1 | Phase 2 | United States |
| 770 | NCT00558025 (ClinicalTrials.gov) | October 2007 | 12/11/2007 | Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease | A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR | Parkinson Disease | Drug: Pramipexole Extended Release;Drug: Pramipexole Immediate Release | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 156 | Phase 3 | France;Germany;Netherlands |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 771 | NCT00559871 (ClinicalTrials.gov) | October 2007 | 15/11/2007 | Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Efficacy, Safety and Tolerability of Fipamezole as an Oromucosal Fast Dissolving Tablet in the Treatment of Parkinson's Disease Patients. | Parkinson's Disease | Drug: fipamezole | Juvantia Pharma Ltd | Santhera Pharmaceuticals | Completed | 30 Years | N/A | Both | 180 | Phase 2 | United States;India |
| 772 | EUCTR2006-002937-20-HU (EUCTR) | 20/09/2007 | 17/05/2007 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 773 | EUCTR2007-002874-75-IT (EUCTR) | 10/09/2007 | 14/01/2008 | Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005 | Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005 | Psycosis associated to Parkinson's Disease MedDRA version: 9.1;Level: HLT;Classification code 10027361;Term: Mental disorders due to a general medical condition NEC | Product Name: Melperon | OVATION PHARMACEUTICALS INC | NULL | Not Recruiting | Female: yes Male: yes | 90 | Italy | |||
| 774 | EUCTR2007-003353-90-DE (EUCTR) | 05/09/2007 | 08/08/2007 | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Pramipexole Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Germany;Netherlands;France | |||
| 775 | NCT00594464 (ClinicalTrials.gov) | September 2007 | 21/12/2007 | A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery | An Explorative, Multicenter, Open-label Pilot Trial With Neupro® (Rotigotine Transdermal Patch) Once Daily Treatment Administered Perioperatively in Patients With Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | 80 Years | All | 14 | Phase 4 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 776 | NCT00537485 (ClinicalTrials.gov) | September 2007 | 27/9/2007 | A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients | A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa | Early Parkinson's Disease | Drug: SPM 962;Drug: placebo | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 180 | Phase 2;Phase 3 | Japan |
| 777 | EUCTR2007-003512-57-FR (EUCTR) | 24/08/2007 | 23/07/2007 | Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD) | Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD) | Excessive daytime sleepiness associated to Parkinson disease MedDRA version: 9.1;Level: LLT;Classification code 10041014;Term: Sleepiness MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease | Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 | Bioprojet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | France | |||
| 778 | EUCTR2006-000859-18-DE (EUCTR) | 13/08/2007 | 05/04/2007 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 225 | Portugal;Czech Republic;Germany;Netherlands;Estonia;Italy;Lithuania | |||
| 779 | EUCTR2007-000074-23-HU (EUCTR) | 10/08/2007 | 01/06/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 780 | NCT00335374 (ClinicalTrials.gov) | August 2007 | 8/6/2006 | An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients | An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients | Early Stage Parkinson's Disease | Drug: Pardoprunox | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 202 | Phase 3 | United States;Australia;Czech Republic;Estonia;Germany;India;Italy;Lithuania;Malaysia;Netherlands;Poland;Portugal;South Africa;Taiwan;Thailand;France;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 781 | NCT01286935 (ClinicalTrials.gov) | August 2007 | 23/8/2010 | 18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD | A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic | Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 544 | Phase 3 | NULL |
| 782 | NCT00407095 (ClinicalTrials.gov) | August 2007 | 30/11/2006 | An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations. | An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations. | Advanced Stage Parkinson's Disease | Drug: Pardoprunox | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 140 | Phase 3 | United States;Albania;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Latvia;Lithuania;Peru;Russian Federation;Ukraine |
| 783 | EUCTR2007-000801-30-IT (EUCTR) | 17/07/2007 | 13/11/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - ND | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - ND | Parkinson's Disease Subjects with Motor Fluctuations MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: E2007 | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 726 | Phase 3 | France;Hungary;Estonia;Czech Republic;Spain;Poland;Lithuania;Latvia;Italy | ||
| 784 | EUCTR2006-005318-11-FR (EUCTR) | 06/07/2007 | 10/05/2007 | Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons. | Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons. | maladie de Parkinson MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: APOKINON | CHU Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 785 | NCT00522379 (ClinicalTrials.gov) | July 2007 | 28/8/2007 | Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch | A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine;Other: Placebo | UCB Pharma | NULL | Completed | 30 Years | N/A | All | 514 | Phase 3 | United States;Chile;India;Mexico;Peru |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 786 | NCT00515437 (ClinicalTrials.gov) | July 2007 | 10/8/2007 | A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients | A Multi-Center, Randomized, Double-blind, Placebo-Controlled,Sequential Dose Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients | Drooling | Biological: Botulinum Toxin Type B (Myobloc);Biological: Matched placebo to Myobloc | Solstice Neurosciences | NULL | Completed | 18 Years | 85 Years | All | 54 | Phase 2 | United States |
| 787 | NCT00550238 (ClinicalTrials.gov) | July 2007 | 26/10/2007 | A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Parkinson's Disease Psychosis | Drug: Pimavanserin tartrate (ACP-103) | ACADIA Pharmaceuticals Inc. | NULL | Completed | 40 Years | N/A | All | 459 | Phase 3 | United States;Austria;Belgium;Canada;France;India;Italy;Poland;Portugal;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom |
| 788 | EUCTR2006-006752-35-HU (EUCTR) | 22/06/2007 | 12/04/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3B | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 789 | EUCTR2006-000678-57-CZ (EUCTR) | 18/06/2007 | 02/08/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 790 | EUCTR2007-000074-23-CZ (EUCTR) | 18/06/2007 | 31/05/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 3 | Hungary;Czech Republic;Spain;Austria;Italy;United Kingdom;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 791 | EUCTR2007-000073-39-CZ (EUCTR) | 18/06/2007 | 18/04/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 792 | EUCTR2007-000073-39-HU (EUCTR) | 14/06/2007 | 31/05/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Finland;Hungary;Czech Republic;Austria | ||
| 793 | EUCTR2007-000074-23-SK (EUCTR) | 14/06/2007 | 09/04/2008 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Austria;Italy;United Kingdom;Sweden | ||
| 794 | EUCTR2007-000073-39-SK (EUCTR) | 14/06/2007 | 09/04/2008 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Slovakia;Finland;Austria;Germany | ||
| 795 | EUCTR2006-005438-19-DE (EUCTR) | 12/06/2007 | 28/03/2007 | An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS | An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS | idiopathic Parkinson´s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 4 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 6 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch INN or Proposed INN: Rotigotine | SCHWARZ PHARMA Deutschland GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 796 | EUCTR2006-005861-21-IT (EUCTR) | 11/06/2007 | 05/01/2007 | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC. | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC. | Patients with idiopathic Parkinson's disease with motor fluctuations MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Italy | ||
| 797 | EUCTR2006-000858-45-SE (EUCTR) | 05/06/2007 | 04/04/2007 | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 300 | Finland;Sweden | |||
| 798 | NCT00477672 (ClinicalTrials.gov) | June 2007 | 22/5/2007 | A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Parkinson's Disease Psychosis | Drug: Pimavanserin tartrate (ACP-103);Drug: Placebo | ACADIA Pharmaceuticals Inc. | NULL | Completed | 40 Years | N/A | All | 298 | Phase 3 | United States;Bulgaria;France;India;Russian Federation;Ukraine;United Kingdom |
| 799 | NCT00485069 (ClinicalTrials.gov) | June 2007 | 11/6/2007 | REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study | Post-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients With Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety - | Parkinson Disease;Parkinson's Disease | Drug: ROP;Drug: ROP+L-Dopa | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 123 | Phase 4 | Japan |
| 800 | NCT00571285 (ClinicalTrials.gov) | June 2007 | 7/12/2007 | Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease | Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease | Parkinson's Disease | Dietary Supplement: Vitamin D3;Dietary Supplement: Vitamin D3 - high dose;Dietary Supplement: Placebo | Emory University | NULL | Terminated | 18 Years | 89 Years | All | 31 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 801 | EUCTR2007-000073-39-AT (EUCTR) | 30/05/2007 | 05/06/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 802 | EUCTR2007-000074-23-AT (EUCTR) | 30/05/2007 | 05/06/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 803 | EUCTR2007-000073-39-DE (EUCTR) | 29/05/2007 | 26/02/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Czech Republic;Finland;Austria;Germany | ||
| 804 | EUCTR2007-000074-23-ES (EUCTR) | 29/05/2007 | 02/03/2010 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+. | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+. | Pacientes varones o mujeres, diagnosticados de enfermedad de Parkinson idiopática, al menos dos años antes, con 30 años o más de edad en el momento del diagnóstico, con un estadío entre 2 y 4 en la escala modificada de Hoehn y Yahr en el periodo on.Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim España, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 805 | EUCTR2006-006907-35-ES (EUCTR) | 27/05/2007 | 27/03/2007 | EXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVER | EXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVER | Enfermedad de Parkinson(Parkinson's disease) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3B | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 806 | EUCTR2006-006752-35-ES (EUCTR) | 27/05/2007 | 27/03/2007 | RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover | RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover | Enfermedad de Parkinson(Parkinson's disease) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3B | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 807 | EUCTR2006-006907-35-HU (EUCTR) | 17/05/2007 | 12/04/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3B | Finland;Hungary;United Kingdom;Germany;Spain;Italy;Austria | ||
| 808 | EUCTR2007-000074-23-IT (EUCTR) | 17/05/2007 | 06/04/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa treated patients with advanced Parkinson s disease PD . - ND | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa treated patients with advanced Parkinson s disease PD . - ND | Patients with advanced idiopathic Parkinson s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Trade Name: Sifrol Trade Name: Sifrol | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 809 | EUCTR2007-000074-23-GB (EUCTR) | 11/05/2007 | 29/03/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 810 | EUCTR2006-006907-35-FI (EUCTR) | 09/05/2007 | 21/03/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3B | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 811 | EUCTR2006-006752-35-FI (EUCTR) | 09/05/2007 | 21/03/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3B | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 812 | EUCTR2007-000074-23-SE (EUCTR) | 02/05/2007 | 02/04/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 813 | NCT00479401 (ClinicalTrials.gov) | May 2007 | 25/5/2007 | Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients | A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD). | Early Parkinson Disease (Early PD) | Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 539 | Phase 3 | United States;Argentina;Austria;Czech Republic;Finland;Germany;Hungary;India;Japan;Malaysia;Russian Federation;Slovakia;Taiwan;Ukraine;Brazil |
| 814 | NCT00505843 (ClinicalTrials.gov) | May 2007 | 24/7/2007 | A Study of MK0657 in Parkinson's Disease Patients (0657-006) | A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate Effectiveness of Single-Dose MK0657 in Combination With Levodopa on Motor Symptoms and Dyskinesias in Patients With Parkinson's Disease | Parkinson's Disease | Drug: MK0657;Drug: Comparator: Placebo (unspecified);Drug: Comparator: levodopa;Drug: Comparator: carbidopa | Merck Sharp & Dohme Corp. | NULL | Completed | 40 Years | 80 Years | Both | 18 | Phase 1 | United States |
| 815 | EUCTR2006-002339-26-PT (EUCTR) | 27/04/2007 | 07/03/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Hungary;Portugal;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 816 | EUCTR2007-000073-39-FI (EUCTR) | 25/04/2007 | 06/03/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 817 | EUCTR2007-000307-15-IT (EUCTR) | 24/04/2007 | 23/08/2007 | Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease. | Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease. | Psicosi associata al morbo di Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Melperon INN or Proposed INN: melperon | OVATION PHARMACEUTICALS INC | NULL | Not Recruiting | Female: yes Male: yes | 90 | Italy | |||
| 818 | EUCTR2006-002339-26-ES (EUCTR) | 19/04/2007 | 30/01/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras. | Levodopa treated Parkinson's disease patients with motor fluctuations.Pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 819 | EUCTR2006-006907-35-AT (EUCTR) | 17/04/2007 | 21/05/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3B | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | ||
| 820 | EUCTR2006-006752-35-AT (EUCTR) | 17/04/2007 | 21/05/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3B | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 821 | EUCTR2006-002339-26-DE (EUCTR) | 10/04/2007 | 22/12/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;United Kingdom;Czech Republic;Germany;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 822 | NCT00623363 (ClinicalTrials.gov) | April 2007 | 2/1/2008 | Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease | Parkinson's Disease | Drug: piclozotan;Drug: 0.9% sodium chloride (normal saline) | Asubio Pharmaceuticals, Inc. | NULL | Completed | 40 Years | 85 Years | Both | 27 | Phase 2 | United States;Guatemala;Romania | |
| 823 | NCT00466167 (ClinicalTrials.gov) | April 2007 | 25/4/2007 | Pivotal Study in Advanced Parkinsons Disease Patients | A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD). | Parkinson Disease | Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 32 Years | N/A | All | 517 | Phase 3 | Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom |
| 824 | NCT00460148 (ClinicalTrials.gov) | April 2007 | 11/4/2007 | Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole | An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. | Parkinson Disease | Drug: Ropinirole | GlaxoSmithKline | NULL | Completed | 30 Years | 85 Years | Both | 28 | Phase 2 | Germany;South Africa |
| 825 | EUCTR2006-006209-94-DE (EUCTR) | 15/03/2007 | 26/01/2007 | An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets. | An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets. | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Product Name: Ropinirole Product Code: SK&F101468 INN or Proposed INN: Ropinirole | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 36 | Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 826 | EUCTR2006-002937-20-FR (EUCTR) | 12/03/2007 | 12/02/2007 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone INN or Proposed INN: entacapone | Eisai Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Hungary;Czech Republic;Estonia;France;Spain;Italy;Latvia;Lithuania | |||
| 827 | NCT00443872 (ClinicalTrials.gov) | March 2007 | 3/3/2007 | Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists | Adding Orally Disintegrating Selegiline (Zelapar) to Patients Taking Dopamine Agonists and Experiencing Complications | Parkinson's Disease | Drug: orally disintegrating selegiline (Zelapar) | Parkinson's Disease and Movement Disorder Center of Boca Raton | Valeant Pharmaceuticals International, Inc. | Completed | 30 Years | 90 Years | All | 77 | Phase 4 | United States |
| 828 | NCT00451633 (ClinicalTrials.gov) | March 2007 | 21/3/2007 | The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations | A Randomized, Double Blind, Placebo-Controlled Study To Investigate The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Withdrawn | 30 Years | 80 Years | Both | 0 | Phase 2 | Germany;Italy |
| 829 | NCT00406588 (ClinicalTrials.gov) | March 2007 | 30/11/2006 | SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa in Patients With Parkinson's Disease Experiencing Motor Fluctuations. | Advanced Stage Parkinson's Disease | Drug: Pardoprunox;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 295 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Latvia;Lithuania;Peru;Russian Federation;Ukraine |
| 830 | NCT00437125 (ClinicalTrials.gov) | March 2007 | 16/2/2007 | Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease | An Open Label Pilot Study on the Tolerability of Duloxetine in the Treatment of Depressed Patients With Parkinson's Disease | Major Depressive Disorder;Idiopathic Parkinson Disease | Drug: Duloxetine hydrochloride | Eli Lilly and Company | NULL | Completed | 30 Years | 75 Years | All | 151 | Phase 4 | Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 831 | NCT00455507 (ClinicalTrials.gov) | March 2007 | 2/4/2007 | A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | Placebo-controlled, Double-blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 2 Study) | Parkinson's Disease | Drug: Istradefylline;Drug: Placebo | Kyowa Hakko Kirin Company, Limited | NULL | Completed | 20 Years | N/A | Both | 363 | Phase 2 | Japan |
| 832 | EUCTR2006-005714-12-IT (EUCTR) | 27/02/2007 | 03/08/2007 | A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213 | A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213 | Patients with idiopathic Parkinson's disease who respond to levodopa treatment but who experience peak-effect levodopa-induced dyskinesia and end-of-dose 'wearing-off' motor fluctuations MedDRA version: 6.1;Level: HLT;Classification code 10034005 | Product Name: E2007 Product Code: E2007 INN or Proposed INN: OTHER NERVOUS SYSTEM DRUGS Trade Name: SINEMET INN or Proposed INN: levodopa-carbidopa | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 24 | Italy | |||
| 833 | EUCTR2005-002038-36-GR (EUCTR) | 27/02/2007 | 09/10/2006 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies MedDRA version: 8.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE | H. Lundbeck A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Germany;United Kingdom;France;Spain;Italy;Greece;Austria | |||
| 834 | EUCTR2006-005183-91-LT (EUCTR) | 14/02/2007 | 20/12/2006 | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian study | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian study | Advanced stage Parkinson's disease with motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 220 | Latvia;Lithuania | |||
| 835 | EUCTR2006-005182-20-LT (EUCTR) | 13/02/2007 | 20/12/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | Advanced stage Parkinson's disease with motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS | Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 280 | Latvia;Lithuania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 836 | EUCTR2006-005182-20-LV (EUCTR) | 02/02/2007 | 28/12/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | Advanced stage Parkinson's disease with motor fluctuations. | Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 280 | Latvia;Lithuania | |||
| 837 | EUCTR2006-005183-91-LV (EUCTR) | 02/02/2007 | 11/01/2007 | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan study | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan study | Advanced stage Parkinson's disease with motor fluctuations. | Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | Latvia;Lithuania | |||
| 838 | NCT00427011 (ClinicalTrials.gov) | February 2007 | 24/1/2007 | A Study of E2007 In Patients With Parkinson's Disease | A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing-Off Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Terminated | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 839 | NCT00332917 (ClinicalTrials.gov) | February 2007 | 1/6/2006 | An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients | An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients | Early Stage Parkinson's Disease | Drug: Pardoprunox | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 224 | Phase 3 | United States;Argentina;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Finland;India;Israel;Mexico;New Zealand;Peru;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro |
| 840 | NCT00480701 (ClinicalTrials.gov) | February 2007 | 30/5/2007 | Evaluation of 123-I Iodobenzovesamicol (IBVM) and SPECT Imaging of Healthy Subjects and Patients With Alzheimer Disease | Evaluation of 123-I Iodobenzovesamicol (IBVM) and SPECT as a Marker of Acetylcholine Transporter Density in the Brain of Healthy Subjects and Patients With Alzheimer Disease | Alzheimer Disease;Parkinson Disease | Drug: [123I]-IBVM | Institute for Neurodegenerative Disorders | NULL | Completed | 50 Years | N/A | Both | 26 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 841 | EUCTR2006-000859-18-NL (EUCTR) | 25/01/2007 | 05/04/2007 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 247 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 842 | EUCTR2006-002339-26-HU (EUCTR) | 24/01/2007 | 24/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 843 | EUCTR2006-000678-57-FR (EUCTR) | 09/01/2007 | 10/10/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;Estonia;France;Italy;Lithuania | |||
| 844 | EUCTR2006-000859-18-PT (EUCTR) | 04/01/2007 | 18/09/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 845 | NCT01187966 (ClinicalTrials.gov) | January 2007 | 31/5/2010 | Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease | A Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, and/or an Anticholinergic | Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 669 | Phase 3 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 846 | NCT00855686 (ClinicalTrials.gov) | January 2007 | 3/3/2009 | Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies | A Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies | Parkinson's Disease Dementia;Dementia With Lewy Bodies | Drug: Memantine;Drug: Placebo | H. Lundbeck A/S | NULL | Completed | 50 Years | N/A | Both | 199 | Phase 4 | Germany |
| 847 | NCT00640159 (ClinicalTrials.gov) | January 2007 | 18/3/2008 | Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease | Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease. | Parkinson's Disease | Drug: Zelapar | Baylor College of Medicine | NULL | Completed | 30 Years | 90 Years | Both | 55 | Phase 4 | United States |
| 848 | NCT00427674 (ClinicalTrials.gov) | January 2007 | 25/1/2007 | Assessment of the Biodistribution and Safety of 123-I MZINT in Healthy Subjects and Parkinson Disease Patients | Phase I Evaluation of (123-I)MZINT as a Brain SPECT Tracer of Serotonin Transporters in Healthy Human Subjects | Parkinson Disease | Drug: [123I] mZINT injection and serial dynamic SPECT imaging | Institute for Neurodegenerative Disorders | Molecular NeuroImaging | Terminated | 18 Years | 70 Years | Both | 28 | Phase 1 | United States |
| 849 | EUCTR2006-000678-57-PT (EUCTR) | 29/12/2006 | 10/08/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 850 | EUCTR2005-002654-21-NO (EUCTR) | 28/12/2006 | 06/11/2006 | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. | Trade Name: Duodopa intestinalgel INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 75 | Norway;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 851 | EUCTR2006-002339-26-GB (EUCTR) | 28/12/2006 | 16/10/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;Czech Republic;United Kingdom;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 852 | EUCTR2006-000678-57-DE (EUCTR) | 22/12/2006 | 06/10/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 376 | Portugal;United Kingdom;Czech Republic;Germany;Netherlands;France;Estonia;Italy;Lithuania | |||
| 853 | EUCTR2006-005509-79-GB (EUCTR) | 21/12/2006 | 07/12/2006 | A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease | A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease | Idiopathic Parkinson's Disease patients who have motor fluctuations with recognisable motor off” periods | Product Name: apomorphine hydrochloride Product Code: VR040 INN or Proposed INN: apomorphine hydrochloride | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United Kingdom | ||
| 854 | EUCTR2005-000314-12-DE (EUCTR) | 19/12/2006 | 25/01/2007 | Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006 | Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil | Institut de Recherches Internationales Servier | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Spain;Germany | ||
| 855 | EUCTR2006-005860-14-IT (EUCTR) | 19/12/2006 | 17/03/2009 | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND | PATIENTS WITH IDIOPATHIC PARKINSON?S DISEASE WITH MOTOR FLUCTUATIONS MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 856 | EUCTR2006-000858-45-FI (EUCTR) | 18/12/2006 | 26/06/2006 | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 300 | Finland;Sweden | |||
| 857 | EUCTR2006-002339-26-IT (EUCTR) | 16/12/2006 | 05/06/2007 | Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303 | Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303 | Levodopa treated Parkinson's Disease Patients with Motor Fluctuations MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: E2007 | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Phase 3 | Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 858 | EUCTR2006-002937-20-CZ (EUCTR) | 14/12/2006 | 24/10/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 859 | EUCTR2006-002937-20-EE (EUCTR) | 11/12/2006 | 19/10/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 860 | EUCTR2006-002937-20-LT (EUCTR) | 04/12/2006 | 02/11/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone INN or Proposed INN: entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 861 | EUCTR2005-002038-36-FR (EUCTR) | 01/12/2006 | 24/08/2010 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE | H. Lundbeck A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Germany;United Kingdom;France;Spain;Italy;Greece;Austria | |||
| 862 | NCT00036296 (ClinicalTrials.gov) | December 2006 | 8/5/2002 | Effects of Talampanel on Patients With Advanced Parkinson's Disease | Effects of Talampanel on Patients With Advanced Parkinson's Disease Who Have Been on Sinemet for More Than 5 Years and Have Dyskinesia (Abnormal Involuntary Movements) | Dyskinesias;Parkinson Disease;Movement Disorders | Drug: talampanel | Teva Pharmaceutical Industries | NULL | Completed | 40 Years | 85 Years | Both | 22 | Phase 1;Phase 2 | United States;Canada |
| 863 | NCT01631812 (ClinicalTrials.gov) | December 2006 | 25/6/2012 | A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients | An Open-label Long-term Extension Trial From Late Phase II of SPM962 (243-05-001) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 130 | Phase 2 | Japan |
| 864 | EUCTR2005-002038-36-DE (EUCTR) | 29/11/2006 | 19/01/2007 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Trade Name: Ebixa Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE | H. Lundbeck A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;France;Spain;Italy;Greece;Austria | |||
| 865 | EUCTR2006-001755-36-GB (EUCTR) | 20/11/2006 | 29/09/2006 | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Germany;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 866 | EUCTR2006-004112-51-IT (EUCTR) | 14/11/2006 | 04/12/2006 | A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND | A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND | Parkinson s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: SIRIO*30CPR EFF 25MG+100MG INN or Proposed INN: Melevodopa and decarboxylase inhibitor Trade Name: SINEMET*50CPR 100MG+25MG INN or Proposed INN: LEVODOPA DC.IT FU INN or Proposed INN: CARBIDOPA FU | VERNALIS DEVELOPMENT LIMITED | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 867 | EUCTR2006-000678-57-GB (EUCTR) | 14/11/2006 | 30/05/2007 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | France;Portugal;Estonia;Czech Republic;Lithuania;Netherlands;Germany;Italy;United Kingdom | |||
| 868 | EUCTR2006-000678-57-LT (EUCTR) | 07/11/2006 | 07/09/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 869 | EUCTR2006-000859-18-LT (EUCTR) | 07/11/2006 | 07/09/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 870 | EUCTR2006-001793-24-PT (EUCTR) | 07/11/2006 | 31/07/2006 | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536 | Product Name: Nebicapone Product Code: BIA 3-202 Trade Name: COMTAN® Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202 | BIAL - Portela & Cª, SA | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Austria | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 871 | EUCTR2006-000859-18-EE (EUCTR) | 03/11/2006 | 01/09/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 872 | EUCTR2006-000678-57-EE (EUCTR) | 03/11/2006 | 01/09/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 873 | EUCTR2006-004582-33-GB (EUCTR) | 03/11/2006 | 23/01/2012 | A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease | A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease | Hypomobility (off or freezing) episodes associated with advanced Parkinson's disease | Product Name: Apomorphine hydrochloride Product Code: VR040 | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | United Kingdom | ||
| 874 | EUCTR2006-002937-20-LV (EUCTR) | 01/11/2006 | 02/11/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 875 | EUCTR2006-002339-26-CZ (EUCTR) | 01/11/2006 | 21/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 876 | NCT00491998 (ClinicalTrials.gov) | November 2006 | 26/6/2007 | PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets | Randomised, Double-blind, Double-dummy, Two-period, Cross-over Study to Determine the PK, PD and Safety of Multiple Doses of V1512 Effervescent Tablets in Parkinson's Disease Patients Compared to Sinemet® Oral Tablets | Parkinson's Disease | Drug: V1512;Drug: V1512 and Entacapone | Vernalis (R&D) Ltd | Cita NeuroPharmaceuticals;INC Research | Completed | 30 Years | N/A | Both | 27 | Phase 1;Phase 2 | Italy |
| 877 | NCT00397228 (ClinicalTrials.gov) | November 2006 | 6/11/2006 | ALTROPANE® SPECT Imaging in Patients With Parkinson Disease | Optimizing the Performance of ALTROPANE® SPECT Imaging in Patients With Parkinson Disease | Parkinson Disease | Drug: ALTROPANE® | Molecular NeuroImaging | Institute for Neurodegenerative Disorders | Completed | 30 Years | N/A | Both | 27 | Phase 2 | United States |
| 878 | NCT00402233 (ClinicalTrials.gov) | November 2006 | 19/11/2006 | A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients | A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson's Disease Patients (PramiBID) | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 31 Years | N/A | All | 312 | Phase 4 | United States |
| 879 | NCT00360308 (ClinicalTrials.gov) | November 2006 | 2/8/2006 | Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo and Entacapone Controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: Placebo;Drug: E2007 | Eisai Limited | NULL | Terminated | 30 Years | N/A | All | 723 | Phase 3 | France |
| 880 | NCT00468078 (ClinicalTrials.gov) | November 2006 | 30/4/2007 | Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients | The Single Center, Phase III Clinical Trial to Evaluate the Efficacy and the Safety of [18F]FPCIT Positron Emission Tomography in Parkinson's Disease and Essential Tremor Patients | Parkinson's Disease | Procedure: PET/CT;Drug: F-18 FPCIT | Asan Medical Center | NULL | Completed | 40 Years | N/A | Both | 78 | Phase 3 | Korea, Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 881 | NCT00335166 (ClinicalTrials.gov) | November 2006 | 8/6/2006 | SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease | A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease. | Early Stage Parkinson Disease | Drug: Pardaprunox;Drug: pramipexole;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 330 | Phase 3 | United States;Australia;Czech Republic;Estonia;France;Germany;India;Italy;Lithuania;Malaysia;Netherlands;Poland;Portugal;South Africa;Spain;Taiwan;Thailand;United Kingdom |
| 882 | EUCTR2005-002038-36-GB (EUCTR) | 31/10/2006 | 09/10/2006 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies MedDRA version: 8.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | H. Lundbeck A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | France;Greece;Spain;Austria;Germany;Italy;United Kingdom | |||
| 883 | EUCTR2006-002339-26-EE (EUCTR) | 20/10/2006 | 15/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 884 | EUCTR2006-002339-26-SE (EUCTR) | 19/10/2006 | 22/09/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Lithuania;Sweden | |||
| 885 | EUCTR2006-002339-26-BE (EUCTR) | 16/10/2006 | 24/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 886 | EUCTR2006-000858-45-SK (EUCTR) | 11/10/2006 | 28/09/2006 | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochlo | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Slovakia;Finland;Sweden | ||
| 887 | EUCTR2006-002339-26-LT (EUCTR) | 05/10/2006 | 07/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 888 | NCT00399477 (ClinicalTrials.gov) | October 2006 | 10/11/2006 | A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease | Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD) | Parkinson's Disease | Drug: rasagiline mesylate;Drug: Rasagiline mesylate plus Mirapex;Drug: Rasagiline mesylate with Levodopa;Drug: Rasagiline mesylate with Requip | Teva Neuroscience, Inc. | NULL | Completed | 30 Years | N/A | Both | 200 | Phase 4 | United States |
| 889 | NCT00360412 (ClinicalTrials.gov) | October 2006 | 2/8/2006 | A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Terminated | 30 Years | N/A | Male | 997 | Phase 3 | Germany |
| 890 | NCT00391898 (ClinicalTrials.gov) | October 2006 | 24/10/2006 | Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off | A 3-month, Multi-center, Double-blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing-off With Levodopa | Parkinson's Disease | Drug: Levodopa/carbidopa/entacapone;Drug: Levodopa/carbidopa | Novartis | NULL | Completed | 30 Years | 80 Years | All | 95 | Phase 4 | Spain |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 891 | NCT03103399 (ClinicalTrials.gov) | September 26, 2006 | 28/3/2017 | Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon | A Multicentre, Double-blind, Randomised, Active- and Placebo-controlled Trial to Investigate the Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon Treated With Levodopa/Carbidopa or Levodopa/Benserazide | Parkinson Disease | Drug: Comtan®;Drug: Nebicapone;Drug: Levodopa/DDCI;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 30 Years | 80 Years | All | 254 | Phase 2 | NULL |
| 892 | EUCTR2006-002339-26-AT (EUCTR) | 25/09/2006 | 18/10/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 893 | EUCTR2005-002038-36-AT (EUCTR) | 22/09/2006 | 09/10/2006 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE | H. Lundbeck A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;United Kingdom;France;Spain;Italy;Greece;Austria | |||
| 894 | EUCTR2006-000678-57-IT (EUCTR) | 14/09/2006 | 26/06/2007 | A multicenter, randomized, double-blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson's Disease. - ND | A multicenter, randomized, double-blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson's Disease. - ND | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: Pramipexole INN or Proposed INN: Pramipexole Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 | SOLVAY PHARMACEUTICALS B.V. | NULL | Not Recruiting | Female: yes Male: yes | 390 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 895 | EUCTR2006-000859-18-CZ (EUCTR) | 11/09/2006 | 02/08/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 896 | EUCTR2005-001006-12-CZ (EUCTR) | 06/09/2006 | 24/08/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea | Axxonis Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Germany;Czech Republic;Italy;Austria | ||
| 897 | EUCTR2004-005234-39-LV (EUCTR) | 06/09/2006 | 29/09/2006 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 898 | EUCTR2005-004949-34-SE (EUCTR) | 06/09/2006 | 27/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Finland;Germany;United Kingdom;Spain;Italy;Austria;Sweden | |||
| 899 | NCT00208611 (ClinicalTrials.gov) | September 2006 | 13/9/2005 | Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinson's Disease | Assessment of Cobalamin Status and Responses to Supplementation in Patients With Parkinson's Disease : a Pilot Study | Parkinson's Disease | Dietary Supplement: Vitamin B12 Supplementation | Emory University | National Institutes of Health (NIH) | Terminated | 21 Years | N/A | Both | 57 | Phase 2;Phase 3 | United States |
| 900 | NCT00462007 (ClinicalTrials.gov) | September 2006 | 17/4/2007 | Study to Evaluate Initiation of Stalevo in Early Wearing-off | Efficacy and Safety of Stalevo® in Subjects With Early Wearing-off Identified Using a Screening Tool WOQ-9; an Open, Non-randomised, Multinational, Multicentre 6-week Direct Switch Study in Levodopa-treated Parkinson's Disease Patients | Parkinson's Disease | Drug: Stalevo | Orion Corporation, Orion Pharma | NULL | Completed | 35 Years | N/A | Both | 115 | Phase 4 | Germany;Sweden;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 901 | EUCTR2005-006033-32-SE (EUCTR) | 15/08/2006 | 22/06/2006 | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 440 | Finland;Slovakia;Sweden | |||
| 902 | EUCTR2005-004314-33-PT (EUCTR) | 09/08/2006 | 10/05/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Hungary;Portugal;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 903 | EUCTR2006-001755-36-SE (EUCTR) | 09/08/2006 | 30/06/2006 | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone | Orion Corporation Orion Pharma, FI-02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Germany;Sweden | |||
| 904 | EUCTR2005-004949-34-DE (EUCTR) | 04/08/2006 | 30/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: SIFROL Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 905 | EUCTR2006-000678-57-NL (EUCTR) | 03/08/2006 | 04/04/2007 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 906 | NCT01628848 (ClinicalTrials.gov) | August 2006 | 24/6/2012 | A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients | A Placebo-controlled Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa | Parkinson's Disease | Drug: SPM 962;Drug: Placebo | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 174 | Phase 2 | Japan |
| 907 | NCT00368108 (ClinicalTrials.gov) | August 2006 | 22/8/2006 | Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: 2 mg perampanel;Drug: 4 mg perampanel;Drug: placebo comparator | Eisai Inc. | NULL | Completed | 30 Years | N/A | All | 752 | Phase 3 | United States;Canada |
| 908 | EUCTR2006-001793-24-AT (EUCTR) | 31/07/2006 | 24/07/2006 | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536 | Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202 | BIAL - Portela & Cª, SA | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Austria | |||
| 909 | EUCTR2006-003717-41-IT (EUCTR) | 13/07/2006 | 12/07/2007 | EVALUATE THE TOLERABILITY AND EFFICACY OF OMEGA 3 ON MOOD ANDMOTOR SYMPTOMS OF PATIENTS SUFFERING FROM PARKINSON DISEASE - ND | EVALUATE THE TOLERABILITY AND EFFICACY OF OMEGA 3 ON MOOD ANDMOTOR SYMPTOMS OF PATIENTS SUFFERING FROM PARKINSON DISEASE - ND | MOOD DEPRESSION MedDRA version: 6.1;Level: PT;Classification code 10012374 | POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 910 | EUCTR2006-000680-28-ES (EUCTR) | 07/07/2006 | 22/05/2006 | Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI | Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI | Enfermedad de Parkinson (Parkinson Disease) | Trade Name: Stalevo 100 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA Trade Name: Sinemet plus Product Name: Sinemet plus (levodopa/carbidopa) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Stalevo 150 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA | NOVARTIS FARMACEUTICA, S.A | NULL | Not Recruiting | Female: yes Male: yes | 200 | Spain | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 911 | NCT00354133 (ClinicalTrials.gov) | July 2006 | 19/7/2006 | Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinson's Disease | The Effect of Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) on Quality of Life in Comparison to Best Medical Treatment in Patients With Complicated Parkinson's Disease and Preserved Psychosocial Competence (EARLYSTIM-study) | Parkinson Disease | Device: Kinetra and Soletra (neurostimulator, Medtronic);Drug: Best Medical Treatment | German Parkinson Study Group (GPS) | University Hospital Schleswig-Holstein;Assistance Publique - Hôpitaux de Paris;KKS Netzwerk | Active, not recruiting | 18 Years | 60 Years | All | 251 | Phase 4 | France;Germany |
| 912 | NCT00408915 (ClinicalTrials.gov) | July 2006 | 5/12/2006 | Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous Infusion | Double-blind, Placebo-controlled, Randomized, Multicentre Phase II/III Study to Evaluate the Efficacy and Safety of Lisuride, Applied Subcutaneously by Means of a Minipump in Patients With Advanced Parkinson's Disease Refractory to Conventional Oral Therapy | Parkinson's Disease | Drug: Continuous Subcutaneous Lisuride Infusion | Axxonis Pharma AG | NULL | Completed | 18 Years | 75 Years | Both | 60 | Phase 3 | Germany |
| 913 | EUCTR2006-000361-11-GB (EUCTR) | 23/06/2006 | 01/02/2006 | A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients - Parkinson's Disease FPFS-1169 Proof of Concept Study (RD639/24201) | A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients - Parkinson's Disease FPFS-1169 Proof of Concept Study (RD639/24201) | Treatment of Parkinson's Disease MedDRA version: 8.0;Classification code 10029205 | Fujimoto Pharmaceutical Corporation | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | United Kingdom | |||
| 914 | EUCTR2005-004314-33-DE (EUCTR) | 21/06/2006 | 01/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;United Kingdom;Germany;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 915 | NCT00331149 (ClinicalTrials.gov) | June 20, 2006 | 26/5/2006 | A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa. | Parkinson Disease | Drug: Ropinirole prolonged release;Drug: ropinirole immediate release | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 343 | Phase 3 | Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 916 | EUCTR2005-004949-34-GB (EUCTR) | 19/06/2006 | 24/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease The main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease The main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Boehringer Ingelheim Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 917 | EUCTR2005-006033-32-SK (EUCTR) | 13/06/2006 | 02/05/2006 | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 440 | Finland;Slovakia;Sweden | |||
| 918 | NCT00269516 (ClinicalTrials.gov) | June 2006 | 22/12/2005 | SLV308 for Treatment of Patients With Early Parkinson's Disease | A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease | Early Stage Parkinson's Disease | Drug: pardoprunox;Drug: Pardoprunox;Drug: Placebo | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 468 | Phase 3 | United States;Argentina;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Finland;India;Israel;Mexico;New Zealand;Peru;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro |
| 919 | EUCTR2005-004949-34-ES (EUCTR) | 29/05/2006 | 21/04/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 920 | EUCTR2005-004314-33-ES (EUCTR) | 19/05/2006 | 15/03/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Phase 3 | Portugal;Czech Republic;Hungary;Estonia;Belgium;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 921 | EUCTR2005-004949-34-FI (EUCTR) | 17/05/2006 | 21/04/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim | Boehringer Ingelheim Finland Ky | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Finland;Germany;United Kingdom;Spain;Italy;Austria;Sweden | |||
| 922 | EUCTR2004-005234-39-LT (EUCTR) | 09/05/2006 | 24/03/2006 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Sweden;Lithuania | |||
| 923 | NCT00321854 (ClinicalTrials.gov) | May 2006 | 3/5/2006 | Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD) | A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease. | Parkinson Disease | Drug: pramipexole | Boehringer Ingelheim | NULL | Completed | 30 Years | 79 Years | All | 535 | Phase 4 | United States;Austria;Finland;France;Germany;Italy;Japan;Spain;Sweden;United Kingdom |
| 924 | NCT00329056 (ClinicalTrials.gov) | May 2006 | 22/5/2006 | A Trial of MitoQ for the Treatment of People With Parkinson's Disease | A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients With Parkinson's Disease | Parkinson's Disease | Drug: MitoQ | Antipodean Pharmaceuticals, Inc. | NULL | Completed | 30 Years | N/A | Both | 128 | Phase 2 | Australia;New Zealand |
| 925 | NCT00324896 (ClinicalTrials.gov) | May 2006 | 9/5/2006 | Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone | Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone | Parkinson's Disease;Insomnia | Drug: eszopiclone;Other: placebo | University of Medicine and Dentistry of New Jersey | Sunovion | Completed | 35 Years | 85 Years | All | 30 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 926 | EUCTR2005-005791-32-GB (EUCTR) | 24/04/2006 | 17/02/2006 | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney. MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes) | Hunter-Fleming Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United Kingdom;Sweden | |||
| 927 | EUCTR2005-006033-32-FI (EUCTR) | 20/04/2006 | 06/03/2006 | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 440 | Finland;Slovakia;Sweden | |||
| 928 | EUCTR2005-004949-34-AT (EUCTR) | 18/04/2006 | 21/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Austria GmbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Finland;Germany;United Kingdom;Spain;Italy;Austria;Sweden | |||
| 929 | EUCTR2005-001006-12-AT (EUCTR) | 02/04/2006 | 28/02/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Trade Name: Sifrol, 0,35 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Sifrol, 0,70 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Cabaseril, 1,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Trade Name: Cabaseril, 2,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- | Axxonis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Germany;Czech Republic;Italy;Austria | ||
| 930 | NCT00294554 (ClinicalTrials.gov) | April 2006 | 21/2/2006 | Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and Dementia | Double-Blind Placebo-Controlled Trial of Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and Dementia | Parkinson's Disease;Cognitive Impairment;Dementia | Drug: Memantine;Drug: Placebo Oral Tablet | Johns Hopkins University | Forest Laboratories | Completed | 50 Years | N/A | All | 20 | N/A | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 931 | NCT00461942 (ClinicalTrials.gov) | April 2006 | 17/4/2007 | Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Neuroprotection Effect of Green Tea Polyphenol in De Novo Parkinson's Disease Patients | Parkinson's Disease | Drug: Green Tea Polyphenols (EGCG/ECG) | Xuanwu Hospital, Beijing | Ministry of Health, China;Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | Both | 480 | Phase 2 | China |
| 932 | EUCTR2005-004109-27-SE (EUCTR) | 24/03/2006 | 24/01/2006 | A double-blind, placebo-controlled multi-centre trial of memantine in patients with Parkinsons’ disease dementia or dementia with Lewy bodies - MEMDLBPDD | A double-blind, placebo-controlled multi-centre trial of memantine in patients with Parkinsons’ disease dementia or dementia with Lewy bodies - MEMDLBPDD | Parkinsons disease (PD)and dementia with Lewy bodies (DLB) are both common disease of the elderly. The majority of patients who survive for more than 10 years with PD eventually develope dementia (PDD). The brain changes and clinical presentations of PDD and DLB are similar. The clinical characteristics are cognitive impairment with pronounced visuospatial and executive impairment, visual hallucinations, parkinsonism, fluctuations in cognition and REM sleep disorder. | Trade Name: Ebixa Product Name: Ebixa | Neuropsychiatric clinic | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Sweden | |||
| 933 | EUCTR2005-001032-72-PT (EUCTR) | 23/03/2006 | 11/11/2005 | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | Parkinson disease | Trade Name: Stalevo Product Code: ELC200 INN or Proposed INN: levodopa/carbidopa/entacapone Trade Name: SINEMET Product Name: sinemet INN or Proposed INN: levodopa/carbidopa | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | |||
| 934 | EUCTR2005-001006-12-DE (EUCTR) | 09/03/2006 | 05/09/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea | Axxonis Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Germany;Italy;Austria | ||
| 935 | EUCTR2005-003788-22-SE (EUCTR) | 03/03/2006 | 19/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 1 | Finland;Germany;United Kingdom;Spain;Italy;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 936 | EUCTR2005-004314-33-HU (EUCTR) | 01/03/2006 | 20/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 937 | EUCTR2005-004314-33-GB (EUCTR) | 01/03/2006 | 29/11/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Phase 3 | Portugal;Czech Republic;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 938 | NCT00305331 (ClinicalTrials.gov) | March 2006 | 20/3/2006 | Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease | Phase II Clinical Trial of Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease | Parkinson's Disease;Peripheral Edema | Drug: Domperidone (drug) | University Health Network, Toronto | NULL | Terminated | 30 Years | 90 Years | Both | 25 | Phase 2 | Canada |
| 939 | NCT00393562 (ClinicalTrials.gov) | March 2006 | 26/10/2006 | Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease | Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease | Parkinson's Disease | Drug: modafinil;Drug: methylphenidate | Department of Veterans Affairs | NULL | Withdrawn | 50 Years | 80 Years | Both | 0 | N/A | United States |
| 940 | NCT00141518 (ClinicalTrials.gov) | March 2006 | 30/8/2005 | Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact | A Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia | Advanced Idiopathic Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel (LCIG);Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: percutaneous endoscopic gastrostomy tube (PEG tube);Device: jejunal extension tube (J-tube) | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 99 Years | All | 77 | Phase 4 | Norway;Sweden |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 941 | NCT00297778 (ClinicalTrials.gov) | March 2006 | 28/2/2006 | Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms | A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms | Parkinson Disease;Depression | Drug: Pramipexole;Other: Placebo | Boehringer Ingelheim | NULL | Completed | 30 Years | 80 Years | All | 296 | Phase 4 | Austria;Finland;France;Germany;Italy;Netherlands;Norway;Romania;Russian Federation;South Africa;Spain;Sweden;Ukraine;United Kingdom |
| 942 | EUCTR2005-003788-22-AT (EUCTR) | 22/02/2006 | 18/01/2006 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Austria GmbH | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 1 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 943 | EUCTR2005-001032-72-CZ (EUCTR) | 16/02/2006 | 12/01/2006 | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | Trade Name: Stalevo 100 mg/25 mg / 200 mg Product Code: ELC200 Trade Name: SINEMET CR Product Name: SINEMET CR | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | ||||
| 944 | EUCTR2005-003788-22-ES (EUCTR) | 09/02/2006 | 28/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Mirapexin / Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 1 | Finland;Germany;United Kingdom;Spain;Italy;Sweden | ||
| 945 | EUCTR2005-004314-33-SE (EUCTR) | 03/02/2006 | 13/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 946 | EUCTR2005-004314-33-BE (EUCTR) | 02/02/2006 | 24/11/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 947 | EUCTR2005-004314-33-LT (EUCTR) | 01/02/2006 | 03/01/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Sweden;Lithuania | |||
| 948 | EUCTR2005-003788-22-DE (EUCTR) | 01/02/2006 | 07/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 1 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 949 | EUCTR2005-004314-33-CZ (EUCTR) | 01/02/2006 | 11/01/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Estonia;Czech Republic;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 950 | NCT00286897 (ClinicalTrials.gov) | February 2006 | 3/2/2006 | The Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Limited | NULL | Completed | 30 Years | N/A | Both | 702 | Phase 3 | Austria;Belgium;Czech Republic;Estonia;France;Germany;Hungary;Israel;Italy;Lithuania;Poland;Portugal;Serbia;South Africa;Spain;Sweden;United Kingdom;Former Serbia and Montenegro |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 951 | NCT00630500 (ClinicalTrials.gov) | February 2006 | 27/2/2008 | Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB) | A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies | Dementia Associated With Parkinson's Disease;Dementia With Lewy Bodies | Drug: Memantine;Drug: Placebo | Helse Stavanger HF | King's College London;Lund University | Completed | N/A | N/A | Both | 75 | Phase 2 | Norway;Sweden;United Kingdom |
| 952 | EUCTR2005-004314-33-IT (EUCTR) | 31/01/2006 | 07/09/2007 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - ND | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - ND | Parkinson's Desease patients with Motor Fluctuations who are on optimised and stabilised therapy with Levodopa. MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: E2007 Product Name: E2007 | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 900 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 953 | EUCTR2005-004314-33-EE (EUCTR) | 17/01/2006 | 24/11/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 954 | EUCTR2005-003788-22-FI (EUCTR) | 17/01/2006 | 07/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Finland Ky | Not Recruiting | Female: yes Male: yes | 318 | Phase 1 | Finland;Germany;United Kingdom;Spain;Italy;Sweden | |||
| 955 | EUCTR2005-003788-22-GB (EUCTR) | 06/01/2006 | 11/11/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 4 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 956 | NCT00273351 (ClinicalTrials.gov) | January 2006 | 4/1/2006 | Imaging and Genetic Biomarkers of Parkinson Disease (PD) Onset and Progression in High-risk Families | Assessment of Pre-symptomatic and Symptomatic Patients With Parkinson Disease to Identify and Characterize Genetic and Phenotypic Biomarkers for Disease Onset and Progression. | Parkinson Disease;Parkinsonian Syndrome | Drug: [123I]B-CIT | Institute for Neurodegenerative Disorders | Department of Defense;Molecular NeuroImaging | Completed | 21 Years | N/A | Both | 62 | Phase 2 | United States |
| 957 | NCT00272688 (ClinicalTrials.gov) | January 2006 | 6/1/2006 | Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit | Continuous Delivery of Levodopa/Carbidopa (Duodopa) in Patients With Advanced Idiopathic Parkinsons Disease - a Health Economic Evaluation | Parkinson Disease | Drug: Levodopa (drug), intraduodenal administration | University Hospital, Akershus | Solvay Pharmaceuticals | Completed | N/A | N/A | Both | 10 | Phase 4 | Norway |
| 958 | NCT00275275 (ClinicalTrials.gov) | January 2006 | 9/1/2006 | Pramipexole Conversion to Ropinirole Controlled Release (CR) | An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease. | Parkinson Disease | Drug: Requip PR;Drug: Mirapex | Rajesh Pahwa, MD | GlaxoSmithKline | Completed | 18 Years | N/A | All | 61 | Phase 3 | United States |
| 959 | EUCTR2005-005120-13-GB (EUCTR) | 21/12/2005 | 02/11/2005 | A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease | A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease | Hypomobility (off” or freezing”) episodes associated with advanced Parkinson’s disease | Product Name: Apomorphine hydrochloride Product Code: VR040 INN or Proposed INN: apomorphine hydrochloride | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United Kingdom | ||
| 960 | EUCTR2005-001032-72-IT (EUCTR) | 25/11/2005 | 26/03/2007 | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa. | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa. | Parkinson s Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Trade Name: Stalevo INN or Proposed INN: ENTACAPONE INN INN or Proposed INN: LEVODOPA INN INN or Proposed INN: CARBIDOPA INN Trade Name: Sinemet INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA ANIDRA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 961 | EUCTR2005-002432-10-MT (EUCTR) | 25/11/2005 | 10/10/2005 | A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease | A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease | Parkinson Disease late stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 60 | Malta | |||
| 962 | EUCTR2005-000444-84-GB (EUCTR) | 23/11/2005 | 13/09/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Spain;Austria;Italy;United Kingdom | ||
| 963 | EUCTR2005-002010-38-DE (EUCTR) | 21/11/2005 | 10/02/2006 | Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study | Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study | Advanced Parkinson´s Disease | Product Name: Trivastal Product Code: S 90049 INN or Proposed INN: Piribedil | Institut de Recherches Internationales Servier (I.R.I.S.) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Germany | |||
| 964 | NCT00253084 (ClinicalTrials.gov) | November 2005 | 11/11/2005 | Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease | A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 12 | Phase 2 | United States |
| 965 | NCT00260793 (ClinicalTrials.gov) | November 2005 | 1/12/2005 | Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease | Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease | Parkinson's Disease | Drug: Ropinirole Hydrochloride | Agarwal, Pinky, M.D. | Colorado Neurology;GlaxoSmithKline | Recruiting | 25 Years | N/A | Both | 20 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 966 | EUCTR2004-005234-39-IE (EUCTR) | 20/10/2005 | 16/08/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 4 | Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden | |||
| 967 | EUCTR2005-000314-12-ES (EUCTR) | 14/10/2005 | 08/09/2005 | Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006 | Product Name: piribedil Product Code: S 90049 - F36 INN or Proposed INN: piribedil Product Name: piribedil Product Code: S 90049 - F38 INN or Proposed INN: piribedil | Institut de Recherches Internationales Servier | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Germany;Spain | |||
| 968 | NCT00517842 (ClinicalTrials.gov) | October 2005 | 15/8/2007 | A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease | A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease | Parkinson Disease | Drug: ViNeuro | Hospital Authority, Hong Kong | Vigconic (International) Ltd. | Completed | 30 Years | N/A | Both | 160 | N/A | China |
| 969 | NCT00199381 (ClinicalTrials.gov) | October 2005 | 12/9/2005 | An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001 | An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline. | Parkinson's Disease | Drug: Istradefylline | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Terminated | 30 Years | N/A | All | 504 | Phase 3 | United States |
| 970 | NCT00134251 (ClinicalTrials.gov) | October 2005 | 22/8/2005 | Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Parallel Group Study Exploring Effects of SLV308 up to 42 mg/Day Administered as an Adjunctive Therapy to L-Dopa in Patients With Advanced Stage Parkinson's Disease | Parkinson's Disease | Drug: SLV308 | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | Phase 3 | Bulgaria;Malta;Serbia;Former Serbia and Montenegro | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 971 | EUCTR2004-005234-39-FI (EUCTR) | 22/09/2005 | 03/06/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 972 | EUCTR2005-000444-84-FI (EUCTR) | 08/09/2005 | 26/07/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;United Kingdom;Spain;Italy | ||
| 973 | NCT00165789 (ClinicalTrials.gov) | September 2005 | 12/9/2005 | A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations | A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Completed | 18 Years | N/A | All | 75 | Phase 2 | United States |
| 974 | NCT00224263 (ClinicalTrials.gov) | September 2005 | 20/9/2005 | Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease Receiving Stable L-dopa/DCI | Parkinson's Disease | Drug: Lingzhi (Ganoderma) | Xuanwu Hospital, Beijing | NULL | Completed | 30 Years | 80 Years | Both | 360 | Phase 2 | China |
| 975 | EUCTR2005-002654-21-SE (EUCTR) | 08/08/2005 | 14/06/2005 | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. | Trade Name: Duodopa intestinal gel INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 976 | EUCTR2004-005234-39-DK (EUCTR) | 04/08/2005 | 31/05/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 977 | NCT00125567 (ClinicalTrials.gov) | August 2005 | 29/7/2005 | Stalevo in Early Wearing-Off Patients | Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off | Idiopathic Parkinson's Disease | Drug: Stalevo (levodopa/carbidopa/entacapone);Drug: Levodopa/carbidopa | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | Both | 223 | Phase 4 | Denmark;Finland;Germany;Ireland;Sweden;United Kingdom |
| 978 | NCT00134966 (ClinicalTrials.gov) | August 2005 | 23/8/2005 | A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa | A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring Levodopa | Parkinson's Disease | Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) | Novartis | NULL | Completed | 30 Years | 80 Years | All | 493 | Phase 3 | United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic |
| 979 | EUCTR2004-001485-41-GB (EUCTR) | 26/07/2005 | 21/06/2005 | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A | Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria). | Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: carbidopa/levodopa Trade Name: Cabaser Product Name: Cabaseril INN or Proposed INN: Cabergoline Trade Name: DaTSCAN Product Name: DatSCAN INN or Proposed INN: Ioflupane [123 I] | Institute for Neurodegenerative Disorders | NULL | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom;Spain | |||
| 980 | EUCTR2004-002844-93-AT (EUCTR) | 20/07/2005 | 15/06/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | Estonia;Spain;Lithuania;Austria;Latvia;Italy;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 981 | EUCTR2004-000835-27-ES (EUCTR) | 18/07/2005 | 23/05/2006 | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | Early idiopathic Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10013113 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals S.P.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 212 | Phase 3 | Spain;Italy | ||
| 982 | EUCTR2004-002844-93-IT (EUCTR) | 06/07/2005 | 21/09/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. - | Parkinson's Disease. MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: Istradefylline Product Code: KW-6002 Other descriptive name: NA | KYOWA HAKKO UK LTD | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | |||||
| 983 | NCT00143026 (ClinicalTrials.gov) | July 2005 | 31/8/2005 | Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States | Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. | Parkinson's Disease | Drug: carbidopa, levodopa, entacapone | Novartis | NULL | Completed | 30 Years | N/A | All | 184 | Phase 4 | Australia;Philippines;Taiwan;Thailand |
| 984 | NCT00125138 (ClinicalTrials.gov) | July 2005 | 27/7/2005 | Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease | Safety and Efficacy of Melperone in the Treatment of Patients With Psychosis Associated With Parkinson's Disease | Parkinson's Disease;Psychotic Disorders | Drug: Melperone HCl;Drug: Placebo | Lundbeck LLC | NULL | Completed | N/A | N/A | All | 90 | Phase 2 | United States;India;Italy |
| 985 | EUCTR2005-000444-84-AT (EUCTR) | 22/06/2005 | 18/05/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Spain;Austria;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 986 | EUCTR2005-004314-33-AT (EUCTR) | 16/06/2005 | 05/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Estonia;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 987 | EUCTR2004-005234-39-SE (EUCTR) | 08/06/2005 | 02/05/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 988 | NCT00642889 (ClinicalTrials.gov) | June 2005 | 21/3/2008 | Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension) | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 227 | Phase 3 | NULL |
| 989 | EUCTR2004-005234-39-GB (EUCTR) | 27/05/2005 | 22/03/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Orion Corporation, ORION PHARMA, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 4 | Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden | |||
| 990 | EUCTR2004-005034-39-GB (EUCTR) | 17/05/2005 | 20/04/2005 | Nicotinamide,vitamin B3, metabolic pathways in patients with early idiopathic parkinson's disease | Nicotinamide,vitamin B3, metabolic pathways in patients with early idiopathic parkinson's disease | Idiopathic Parkinson's disease | Trade Name: Nicotinamide Product Name: NICOTINAMIDE INN or Proposed INN: Nicotinamide | Queen Elizabeth Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 991 | EUCTR2004-002641-12-GB (EUCTR) | 16/05/2005 | 30/06/2005 | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Spain;Austria;Italy;United Kingdom | ||
| 992 | NCT00163085 (ClinicalTrials.gov) | May 2005 | 9/9/2005 | The Effects of an NR2B NMDA Antagonist, CP-101,606, in Patients With Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Explore The Efficacy And Safety Of The NR2B NMDA Antagonist CP-101,606 In Patients With Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: NR2B NMDA Antagonist CP-101,606 (traxoprodil) | Pfizer | NULL | Completed | 30 Years | 80 Years | Both | 12 | Phase 2 | United States |
| 993 | NCT00199433 (ClinicalTrials.gov) | May 2005 | 12/9/2005 | A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients | A Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) as Monotherapy in Subjects With Parkinson's Disease | Parkinson's Disease;Movement Disorder Syndrome | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 160 | Phase 2 | United States |
| 994 | EUCTR2004-001485-41-ES (EUCTR) | 28/04/2005 | 30/01/2006 | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease | Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria). | Trade Name: SINEMET Product Name: carbodopa/levadopa INN or Proposed INN: CARBODOPA LEVADOPA Trade Name: SOLIGEN Product Name: Cabergoline INN or Proposed INN: CABERGOLINA Trade Name: DaTSCAN INN or Proposed INN: Ioflupane [123I] | Institute for Neurodegenerative Disorders | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | United Kingdom;Spain | |||
| 995 | EUCTR2004-002641-12-ES (EUCTR) | 25/04/2005 | 10/07/2006 | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3b | United Kingdom;Spain;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 996 | EUCTR2004-001485-41-AT (EUCTR) | 20/04/2005 | 16/03/2005 | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A | Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria). | Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: carbidopa/levodopa Trade Name: Cabaseril Product Name: Cabaseril INN or Proposed INN: Cabergoline Trade Name: DaTSCAN Product Name: DatSCAN INN or Proposed INN: Ioflupane [123 I] | Institute for Neurodegenerative Disorders | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Spain;Austria;United Kingdom | |||
| 997 | EUCTR2004-000817-20-IT (EUCTR) | 06/04/2005 | 13/04/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: istradefylline Product Code: KW-6002 Other descriptive name: NA Trade Name: COMTAN 200* 60 CPR 200 MG Product Name: NA Product Code: NA INN or Proposed INN: Entacapone | KYOWA HAKKO UK LTD | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 998 | EUCTR2004-002844-93-ES (EUCTR) | 01/04/2005 | 04/11/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| 999 | NCT00199355 (ClinicalTrials.gov) | April 2005 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa] | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Hakko Kirin Company, Limited | NULL | Completed | 30 Years | N/A | Both | 75 | Phase 2 | Japan |
| 1000 | EUCTR2004-001593-10-GB (EUCTR) | 21/03/2005 | 25/08/2005 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1 | Treatment-Associated Dyskinesia in Parkinson's Disease | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Italy;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1001 | EUCTR2004-002844-93-EE (EUCTR) | 08/03/2005 | 07/03/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| 1002 | EUCTR2004-002598-21-GB (EUCTR) | 02/03/2005 | 07/07/2005 | A phase 3b, open-label. multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | A phase 3b, open-label. multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | Idiopathic Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Austria;United Kingdom | ||
| 1003 | NCT00203957 (ClinicalTrials.gov) | March 2005 | 13/9/2005 | Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on Levodopa | A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy | Parkinson's Disease | Drug: Istradefylline | University of Chicago | NULL | Completed | 18 Years | N/A | Both | 10 | Phase 3 | United States |
| 1004 | NCT02834507 (ClinicalTrials.gov) | March 2005 | 13/7/2016 | Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients | A Double-blind, Randomised, Placebo- and Active-controlled, Cross-over Study to Investigate the Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients | Parkinson's Disease (PD) | Drug: Placebo;Drug: BIA 3-202;Drug: Comtan®;Drug: Sinemet® | Bial - Portela C S.A. | NULL | Completed | 30 Years | 75 Years | Both | 19 | Phase 2 | NULL |
| 1005 | EUCTR2004-002844-93-LT (EUCTR) | 08/02/2005 | 03/01/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1006 | EUCTR2004-001594-25-AT (EUCTR) | 02/02/2005 | 29/12/2004 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Austria | ||
| 1007 | EUCTR2004-000817-20-AT (EUCTR) | 02/02/2005 | 29/12/2004 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Lithuania;Austria;Latvia;Italy | |||
| 1008 | EUCTR2004-002844-93-GB (EUCTR) | 01/02/2005 | 23/02/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | Italy;Latvia;Lithuania;United Kingdom;Estonia;Spain | ||||
| 1009 | NCT00505687 (ClinicalTrials.gov) | February 2005 | 20/7/2007 | An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease | A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 31 Years | N/A | All | 186 | Phase 3 | United States;Austria;Germany;Israel;Italy;South Africa;Spain;United Kingdom |
| 1010 | EUCTR2004-002844-93-LV (EUCTR) | 28/01/2005 | 31/01/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1011 | EUCTR2004-002641-12-AT (EUCTR) | 21/01/2005 | 17/12/2004 | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3b | Spain;Austria;Italy;United Kingdom | ||
| 1012 | NCT00286949 (ClinicalTrials.gov) | January 6, 2005 | 3/2/2006 | Treatment of Executive Dysfunction in Parkinson's Disease | Atomoxetine for the Treatment of Executive Dysfunction in Patients With Parkinson's Disease: A Pilot Open-label Study | Parkinson's Disease | Drug: Atomoxetine | Johns Hopkins University | Eli Lilly and Company | Completed | 21 Years | 65 Years | All | 12 | N/A | United States |
| 1013 | NCT00129181 (ClinicalTrials.gov) | January 2005 | 9/8/2005 | Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease | A Single-blinded Assessment of the Short-term Effects of Cabergoline vs. Carbidopa/Levodopa on SPECT Dopamine Transporter Density in Out-patient Subjects With Parkinson's Disease | Parkinson Disease;Parkinsonian Syndrome | Drug: cabergoline;Drug: carbidopa/levodopa;Procedure: DATscan and SPECT imaging | Institute for Neurodegenerative Disorders | Pfizer;GE Healthcare | Completed | 40 Years | N/A | Both | 30 | N/A | Austria;Germany;Italy;Spain;United Kingdom |
| 1014 | NCT00219284 (ClinicalTrials.gov) | January 2005 | 30/6/2005 | Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease | A Prospective, Multi-center, Randomized, Open-label Study With Blinded Raters to Evaluate the Effects of Immediate Versus Delayed Switch to Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing Off | Parkinson's Disease With End of Dose Wearing Off | Drug: Carbidopa/levodopa/entacapone | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 85 Years | All | 359 | Phase 4 | United States;Puerto Rico |
| 1015 | NCT01634243 (ClinicalTrials.gov) | January 2005 | 27/6/2012 | A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients | A Open-label Dose-ranging Study for SPM 962 in Parkinson's Disease Patients | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 64 | Phase 2 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1016 | NCT00144300 (ClinicalTrials.gov) | January 2005 | 2/9/2005 | Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients | A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients | Parkinson Disease | Drug: Mirapex;Drug: Requip | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 246 | Phase 4 | United States |
| 1017 | EUCTR2004-001594-25-FI (EUCTR) | 30/12/2004 | 26/10/2004 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain | ||
| 1018 | EUCTR2004-002598-21-AT (EUCTR) | 22/12/2004 | 17/11/2004 | A phase 3b, open-label, multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | A phase 3b, open-label, multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3b | Austria;United Kingdom | ||
| 1019 | EUCTR2004-002609-66-IT (EUCTR) | 21/12/2004 | 03/03/2006 | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease | Idiopathic Parkinson Disease in early stage MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: rotigotine Product Code: SPM 926 Trade Name: REQUIP 21 CPR 0,25 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 0,5 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 1 MG INN or Proposed INN: Ropinirole Trade Name: REQUIP 21 CPR 2 MG INN or Proposed INN: Ropinirole | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Germany;Italy | ||
| 1020 | EUCTR2004-000817-20-ES (EUCTR) | 10/12/2004 | 04/05/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtan Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1021 | EUCTR2004-002609-66-DE (EUCTR) | 06/12/2004 | 22/04/2005 | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Germany;Italy | ||
| 1022 | EUCTR2004-000835-27-IT (EUCTR) | 03/12/2004 | 21/07/2005 | A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: Safinamide Product Code: NW-1015 | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain;Italy | |||
| 1023 | EUCTR2004-001593-10-IT (EUCTR) | 02/12/2004 | 03/01/2005 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Name: Sarizotan hydrochloride Product Code: EMD 128130 INN or Proposed INN: Sarizotan hydrochloride | MERCK S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | United Kingdom;Italy | |||
| 1024 | EUCTR2004-000833-12-ES (EUCTR) | 02/12/2004 | 23/11/2004 | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist. | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist. | Early idiopathic Parkinson’s disease MedDRA version: 7.0;Level: LLT;Classification code 10013113 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Spain;Italy | ||
| 1025 | EUCTR2004-000833-12-IT (EUCTR) | 02/12/2004 | 15/03/2005 | A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1026 | EUCTR2004-000185-12-IT (EUCTR) | 02/12/2004 | 27/06/2005 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Trade Name: Stalevo Product Name: NA Product Code: NA INN or Proposed INN: carbidopa INN or Proposed INN: levodopa INN or Proposed INN: entecapone Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) Trade Name: Stalevo Product Name: NA Product Code: NA INN or Proposed INN: carbidopa INN or Proposed INN: levodopa INN or Proposed INN: entecapone Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;United Kingdom;Italy;Sweden | |||
| 1027 | NCT00243945 (ClinicalTrials.gov) | December 2004 | 24/10/2005 | A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease | A Phase 3b, Open-Label, Multicenter, Multinational Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders in Patients With Idiopathic Parkinson's Disease | IDIOPATHIC PARKINSON'S DISEASE | Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 58 | Phase 3 | Germany |
| 1028 | NCT00643045 (ClinicalTrials.gov) | December 2004 | 21/3/2008 | Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | A Phase III, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of a Low (50 100 mg/Day) and High (150 200 mg/Day) Dose Range of Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | Idiopathic Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 269 | Phase 3 | NULL |
| 1029 | EUCTR2004-000185-12-AT (EUCTR) | 25/11/2004 | 21/10/2004 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;Austria;Italy;United Kingdom;Sweden | |||
| 1030 | EUCTR2004-001594-25-ES (EUCTR) | 24/11/2004 | 02/11/2004 | A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2 | A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Name: Sarizotan Product Code: EMD 128130 INN or Proposed INN: Sarizotan Hydrochloride | MERCK KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1031 | NCT01518309 (ClinicalTrials.gov) | November 17, 2004 | 16/12/2008 | An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients | An Open-Label Safety Study of Pimavanserin in Parkinson's Disease Patients | Parkinson's Disease Psychosis | Drug: pimavanserin tartrate (ACP-103) | ACADIA Pharmaceuticals Inc. | NULL | Completed | N/A | N/A | All | 39 | Phase 2 | United States |
| 1032 | EUCTR2004-000185-12-SE (EUCTR) | 11/11/2004 | 03/09/2004 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;United Kingdom;Italy;Sweden | |||
| 1033 | EUCTR2004-000817-20-GB (EUCTR) | 08/11/2004 | 11/02/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Phase 3 | Spain;Lithuania;Austria;Latvia;Italy;United Kingdom | ||
| 1034 | NCT01634360 (ClinicalTrials.gov) | November 2004 | 3/7/2012 | Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations | A 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With Wearing Off Motor Fluctuations and on Period Dyskinesias | Parkinson's Disease | Drug: Perampanel | Eisai Inc. | NULL | Terminated | N/A | N/A | All | 185 | Phase 2 | NULL |
| 1035 | NCT00243971 (ClinicalTrials.gov) | November 2004 | 24/10/2005 | A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease | A Phase 3, Randomized, Open-Label, Two-Arm, Parallel-Group, Multicenter, Multinational Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: SPM 962 | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | Phase 3 | Germany | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1036 | NCT00296946 (ClinicalTrials.gov) | November 2004 | 23/2/2006 | Ipratropium Spray for Drooling Saliva in Parkinson's Disease | Phase II Clinical Trial of Ipratropium Bromide Spray as a Treatment for Sialorrhea in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ipratropium bromide (drug) | University Health Network, Toronto | Parkinson's Disease Foundation | Completed | 30 Years | N/A | All | 20 | Phase 2 | Canada |
| 1037 | NCT00199394 (ClinicalTrials.gov) | November 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Hakko Kirin UK, Ltd. | NULL | Completed | 30 Years | N/A | Both | 405 | Phase 3 | United Kingdom |
| 1038 | EUCTR2004-000361-35-IT (EUCTR) | 22/10/2004 | 23/05/2005 | A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS. | A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS. | Parkinson's disease. MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: NA Product Code: E2007 Other descriptive name: NA | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | Czech Republic;Italy | ||||
| 1039 | EUCTR2004-000817-20-LV (EUCTR) | 22/10/2004 | 27/10/2004 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 1040 | EUCTR2004-000361-35-CZ (EUCTR) | 18/10/2004 | 22/10/2004 | A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS. | A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS. | Parkinson's Disease | Product Name: MARS Product Code: E2007 Other descriptive name: MARS Other descriptive name: MARS Other descriptive name: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 225 | Czech Republic;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1041 | EUCTR2004-000148-26-ES (EUCTR) | 13/10/2004 | 16/09/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Hungary;Finland;Czech Republic;Spain;Italy;Sweden | ||
| 1042 | EUCTR2004-000148-26-CZ (EUCTR) | 12/10/2004 | 11/10/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Hungary;Finland;Czech Republic;Spain;Italy;Sweden | ||
| 1043 | NCT00199368 (ClinicalTrials.gov) | October 2004 | 12/9/2005 | An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018 | A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Drug: Istradefylline ( KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | Kyowa Hakko Kirin UK, Ltd. | Completed | 30 Years | N/A | Both | 1100 | Phase 3 | United States |
| 1044 | NCT00105508 (ClinicalTrials.gov) | September 30, 2004 | 15/3/2005 | Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | Parkinson's Disease;Dyskinesia | Drug: Sarizotan;Drug: Placebo | EMD Serono | NULL | Completed | 30 Years | N/A | All | 506 | Phase 3 | United States |
| 1045 | EUCTR2004-000148-26-SE (EUCTR) | 29/09/2004 | 05/07/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Hungary;Finland;Czech Republic;Spain;Italy;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1046 | EUCTR2004-000185-12-FI (EUCTR) | 21/09/2004 | 23/07/2004 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;United Kingdom;Italy;Sweden | |||
| 1047 | EUCTR2004-000817-20-LT (EUCTR) | 16/09/2004 | 07/01/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 1048 | EUCTR2004-003355-39-AT (EUCTR) | 14/09/2004 | 08/10/2004 | A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia. | A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia. | Dementia associated with Parkinson's disease | Trade Name: Aricept 5 mg-Filmtabletten Product Name: Aricept 5mg-Filmtabletten | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 468 | Austria | |||
| 1049 | NCT00105521 (ClinicalTrials.gov) | September 2004 | 15/3/2005 | Sarizotan HCl in Patients With Parkinson's Disease Suffering From Treatment-Associated Dyskinesia | A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | Parkinson's Disease;Dyskinesia | Drug: Sarizotan HC1 | EMD Serono | NULL | Completed | 30 Years | N/A | All | 594 | Phase 3 | United States |
| 1050 | NCT00641186 (ClinicalTrials.gov) | September 2004 | 18/3/2008 | Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD) | A Phase II, Eight Week, Multi-Center, Open Label Trial of Xyrem(R) (Sodium Oxybate) for Excessive Daytime Sleepiness and Nocturnal Sleep Disturbance in Patients With Mild to Moderate Parkinson's Disease | Parkinson Disease | Drug: sodium oxybate | Baylor College of Medicine | Jazz Pharmaceuticals | Completed | 30 Years | 75 Years | Both | 30 | Phase 2 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1051 | NCT00099268 (ClinicalTrials.gov) | September 2004 | 10/12/2004 | Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy | A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy | Parkinson's Disease | Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa | Novartis Pharmaceuticals | Orion Corporation, Orion Pharma | Completed | 30 Years | 70 Years | All | 747 | Phase 3 | United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 1052 | NCT00296959 (ClinicalTrials.gov) | September 2004 | 23/2/2006 | Topiramate as a Treatment for Levodopa-Induced Dyskinesia in Parkinson's Disease | Anti-Dyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients With Parkinson's Disease and Levodopa-Induced Dyskinesias | Parkinson's Disease | Drug: topiramate (drug) | University Health Network, Toronto | NULL | Terminated | 30 Years | 75 Years | Both | 20 | Phase 2 | Canada |
| 1053 | NCT00089622 (ClinicalTrials.gov) | August 4, 2004 | 6/8/2004 | Lisuride Patch to Treat Parkinson's Disease | Transcutaneous Lisuride Therapy of Parkinson's Disease | Parkinson Disease | Drug: Intravenous Levodopa;Drug: Lisuride Transdermal System | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 40 Years | 80 Years | All | 40 | Phase 2 | United States |
| 1054 | EUCTR2004-000148-26-FI (EUCTR) | 30/07/2004 | 28/06/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Hungary;Finland;Spain;Italy;Sweden | ||
| 1055 | NCT00174239 (ClinicalTrials.gov) | July 2004 | 9/9/2005 | Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease. | A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients. | Parkinson Disease | Drug: cabergoline;Drug: controlled-release levodopa / carbidopa | Pfizer | NULL | Terminated | 18 Years | 80 Years | Both | 220 | Phase 4 | Australia;Italy;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1056 | NCT00199420 (ClinicalTrials.gov) | July 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa | A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of 10, 20 and 40 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 580 | Phase 3 | United States |
| 1057 | EUCTR2004-000148-26-IT (EUCTR) | 14/06/2004 | 26/07/2007 | A multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopa | A multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopa | Advanced stage Parkinson's Disease | INN or Proposed INN: rotigotine | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Hungary;Finland;Czech Republic;Spain;Italy;Sweden | ||
| 1058 | NCT00199407 (ClinicalTrials.gov) | June 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of a 20 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 230 | Phase 3 | United States |
| 1059 | NCT00211588 (ClinicalTrials.gov) | June 2004 | 13/9/2005 | Galantamine Executive Function in Parkinson's Disease | Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease | Parkinson's Disease | Drug: galantamine | Memorial Hospital of Rhode Island | Ortho-McNeil Neurologics, Inc. | Active, not recruiting | 60 Years | 85 Years | Both | 90 | N/A | United States |
| 1060 | NCT00203138 (ClinicalTrials.gov) | June 2004 | 13/9/2005 | Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease | A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease | Parkinson's Disease | Drug: rasagiline mesylate | Teva Pharmaceutical Industries | NULL | Completed | 35 Years | N/A | Both | 306 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1061 | NCT01172379 (ClinicalTrials.gov) | May 2004 | 26/7/2010 | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With Wearing Off Motor Fluctuations and On Period Dyskinesias | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With Wearing Off Motor Fluctuations and On Period Dyskinesias | Parkinson's Disease | Drug: E2007;Other: Placebo Comparator | Eisai Limited | NULL | Completed | 30 Years | 75 Years | Both | 2 | Phase 2 | Czech Republic;France;Germany;Italy;Serbia;Spain |
| 1062 | NCT00200447 (ClinicalTrials.gov) | March 2004 | 12/9/2005 | An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN) | Assessment of Carbidopa/l-Dopa and Carbidopa/l Dopa/Entacapone on Synaptic Dopamine in Parkinson's Patients: An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN) | Parkinson's Disease | Drug: carbidopa/l-dopa;Drug: carbidopa/l-dopa/entacapone;Drug: Stalevo;Procedure: [123I]-IBZM imaging | Molecular NeuroImaging | NULL | Completed | 30 Years | N/A | Both | 3 | Phase 2 | NULL |
| 1063 | NCT00244387 (ClinicalTrials.gov) | March 2004 | 24/10/2005 | Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa | A Multi-centre, Multi-national, Phase 3, Randomized, Double-blind, Double-dummy, 3- Arm Parallel Group, Placebo- and Pramipexole- Controlled Trial of the Efficacy and Safety of Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa | Parkinson Disease, Idiopathic | Drug: SPM 962 | UCB Pharma | NULL | Completed | 30 Years | N/A | Both | 506 | Phase 3 | Germany |
| 1064 | NCT02248181 (ClinicalTrials.gov) | February 2004 | 22/9/2014 | Post Marketing Surveillance Study of Sifrol® in Patients With Idiopathic Parkinson's Disease | Post Marketing Surveillance Study of Sifrol® - Monotherapy in Patients With Idiopathic Parkinson's Disease | Parkinson Disease | Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 442 | N/A | NULL |
| 1065 | NCT00212693 (ClinicalTrials.gov) | January 2004 | 13/9/2005 | Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan | Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan | Parkinson's Disease | Drug: ONO-2506PO | Ono Pharmaceutical Co. Ltd | NULL | Completed | 20 Years | 79 Years | Both | 165 | Phase 2 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1066 | NCT00220272 (ClinicalTrials.gov) | January 2004 | 16/9/2005 | Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's Disease | A Phase II, Randomized, Multicenter, Multinational, Double-Blind, Placebo-Controlled, Study of the Effect of SR57667B on Dopaminergic Nigro-Striatal Function Assessed by 18F-Dopa PET Imaging in Outpatients With Early Parkinson's Disease | Parkinson Disease | Drug: SR57667B | Sanofi | NULL | Completed | 35 Years | N/A | Both | 183 | Phase 2 | Canada;Finland;France;Netherlands;Spain;Switzerland;United Kingdom |
| 1067 | NCT02231905 (ClinicalTrials.gov) | January 2004 | 3/9/2014 | Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease | Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole | Parkinson Disease | Drug: BI-Sifrol® | Boehringer Ingelheim | NULL | Completed | 20 Years | N/A | Both | 29 | Phase 4 | NULL |
| 1068 | NCT00095810 (ClinicalTrials.gov) | July 2003 | 9/11/2004 | Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease | An Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients With Psychosis Associated With Parkinson's Disease | Parkinson's Disease;Psychoses | Drug: aripiprazole | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka America Pharmaceutical | Completed | 50 Years | N/A | Both | 50 | Phase 4 | United States |
| 1069 | NCT00240409 (ClinicalTrials.gov) | July 2003 | 14/10/2005 | Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson's Disease | A Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole Tablets and Bromocriptine Tablets in Patients With Parkinson's Disease. | Parkinson Disease | Drug: Pramipexole;Drug: Bromocriptine | Boehringer Ingelheim | NULL | Completed | 30 Years | 80 Years | Both | 208 | Phase 3 | China |
| 1070 | NCT00070941 (ClinicalTrials.gov) | July 2003 | 9/10/2003 | SAM-e for the Treatment of Depression in Patients With Parkinson's Disease | SAM-e Treatment of Depression in Parkinson's Disease. | Parkinson's Disease;Depression | Drug: SAM-e;Drug: oral escitalopram;Drug: placebo | New York University School of Medicine | National Center for Complementary and Integrative Health (NCCIH);Office of Dietary Supplements (ODS) | Completed | 30 Years | 80 Years | All | 29 | Phase 2;Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1071 | NCT00228150 (ClinicalTrials.gov) | July 2003 | 26/9/2005 | Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease | A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Outpatients With Early Parkinson's Disease | Parkinson Disease | Drug: SR57667B | Sanofi | NULL | Completed | 35 Years | N/A | Both | 564 | Phase 2 | Austria;Canada;Denmark;France;Germany;Morocco;Netherlands;Portugal;South Africa;Spain;Sweden;Tunisia;United Kingdom |
| 1072 | NCT00381472 (ClinicalTrials.gov) | June 2003 | 26/9/2006 | Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa | A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopa | Parkinson Disease | Drug: Ropinirole | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 393 | Phase 3 | United States;Belgium;Czech Republic;France;Germany;Hungary;Italy;Poland;Spain |
| 1073 | NCT00062738 (ClinicalTrials.gov) | June 2003 | 12/6/2003 | Treatment of Depression in Parkinson's Disease Trial | Treatment of Depression in Patients With Parkinson's Disease | Parkinson Disease;Depression | Drug: paroxetine;Drug: Nortriptyline;Other: placebo | Rutgers, The State University of New Jersey | GlaxoSmithKline | Completed | 35 Years | 80 Years | All | 52 | Phase 2 | United States |
| 1074 | NCT00148486 (ClinicalTrials.gov) | June 2003 | 7/9/2005 | A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE) | A Fourteen-week Placebo-controlled Dose-response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE) | Parkinson Disease | Drug: NS 2330 | Boehringer Ingelheim | NULL | Completed | 40 Years | 80 Years | Both | 261 | Phase 2 | United States;Canada |
| 1075 | NCT00058838 (ClinicalTrials.gov) | April 2003 | 14/4/2003 | Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease | A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease. | Parkinson Disease | Drug: sumanirole | Pfizer | NULL | Completed | 30 Years | N/A | Both | 854 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Colombia;France;Germany;Greece;Italy;Mexico;Peru;Puerto Rico;Spain |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1076 | NCT01327859 (ClinicalTrials.gov) | March 2003 | 30/3/2011 | Safety, Tolerability, and Efficacy of Donepezil (Aricept) in Parkinson' s Disease (PD) Patients With Dementia | A 52-week, Multicentre Open Label Extension Study of the Safety Tolerability and Efficacy of Donepezil (Aricept) in Parkinson's Disease (PD) Patients With Dementia | Parkinson's Disease;Dementia | Drug: Prior Donepezil 5mg;Drug: Prior Donzepezil 10mg;Drug: Prior Placebo | Eisai Inc. | NULL | Completed | 40 Years | N/A | Both | 357 | Phase 3 | United Kingdom |
| 1077 | NCT00148512 (ClinicalTrials.gov) | March 2003 | 7/9/2005 | A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations | A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS) | Parkinson Disease | Drug: 1. Tesofensine (NS 2330) | Boehringer Ingelheim | NULL | Completed | 42 Years | 80 Years | Both | 254 | Phase 2 | Austria;France;Germany;Netherlands;Spain;United Kingdom;El Salvador |
| 1078 | NCT00056524 (ClinicalTrials.gov) | February 2003 | 15/3/2003 | Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter) | An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect. | Alzheimer's Disease;Stroke;Parkinson's Disease;Traumatic Brain Injury | Drug: AVP-923 | Avanir Pharmaceuticals | NULL | Completed | 18 Years | 80 Years | Both | 600 | Phase 3 | United States |
| 1079 | NCT00237263 (ClinicalTrials.gov) | February 2003 | 7/10/2005 | An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United States | An Extension Study to Phase IIb Dose-finding Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off | Parkinson's Disease | Drug: Entacapone | Novartis | NULL | Completed | 20 Years | N/A | All | 285 | Phase 2 | United States |
| 1080 | NCT02248207 (ClinicalTrials.gov) | January 2003 | 22/9/2014 | Tolerability of Sifrol® in Ambulatory Patients Suffering From Parkinson's Disease | Management of Parkinson's Disease Patients at Their First Visits in a Neurological Practice | Parkinson Disease | Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 1293 | N/A | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1081 | NCT00206687 (ClinicalTrials.gov) | January 2003 | 13/9/2005 | STEPS Trial - Spheramine Safety and Efficacy Study | Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease | Parkinson Disease | Biological: Spheramine (BAY86-5280);Procedure: Placebo | Bayer | Titan Pharmaceuticals | Terminated | 30 Years | 70 Years | Both | 71 | Phase 2 | United States;Germany;Spain;Austria;France |
| 1082 | NCT00247247 (ClinicalTrials.gov) | December 2002 | 31/10/2005 | Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off. | Efficacy and Tolerability of Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing-Off Phenomenon | Parkinson's Disease | Drug: Comtess® | Orion Corporation, Orion Pharma | NULL | Completed | 60 Years | N/A | Both | 300 | Phase 4 | Germany |
| 1083 | NCT00209508 (ClinicalTrials.gov) | November 2002 | 13/9/2005 | 2 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PD | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 2-Year Study To Evaluate The Effects Of GPI 1485 On [123I]b-CIT/SPECT Scanning And Clinical Efficacy In Symptomatic PD Patients Receiving Dopamine Agonist Therapy. | Parkinson's Disease | Drug: GPI 1485 | Eisai Inc. | Symphony Neuro Development Company | Completed | 40 Years | 80 Years | Both | 200 | Phase 2 | NULL |
| 1084 | NCT00165815 (ClinicalTrials.gov) | August 2002 | 13/9/2005 | The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia | Dementia With Parkinson's Disease | Drug: ARICEPT | Eisai Limited | NULL | Completed | 40 Years | N/A | Both | Phase 3 | Germany;Ireland | ||
| 1085 | NCT00955045 (ClinicalTrials.gov) | August 2002 | 4/8/2009 | A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy | A Long-Term, Multicenter, Open-Label, Safety Study With a Flexible Dose Range of KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy | Parkinson's Disease | Drug: istradefylline | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | Phase 2;Phase 3 | United States | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1086 | NCT00314288 (ClinicalTrials.gov) | July 2002 | 12/4/2006 | Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia | A Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia | Parkinson's Disease;Dyskinesia | Drug: Sarizotan HCl | EMD Serono | NULL | Completed | 30 Years | N/A | All | 360 | Phase 2 | United States;Belgium;Bulgaria;Canada;France;Germany;Hungary;Portugal;Romania;South Africa;United Kingdom |
| 1087 | NCT00650104 (ClinicalTrials.gov) | May 2002 | 27/3/2008 | Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164 | 101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson's Disease Who Completed the Previous Ropinirole CR Studies 167 or 164 | Parkinson Disease | Drug: Ropinirole XL (formerly CR) | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 76 | Phase 3 | United States;Belgium;France;Netherlands;Norway |
| 1088 | NCT01044992 (ClinicalTrials.gov) | May 2002 | 6/1/2010 | Motor Activation in Multiple System Atrophy and Parkinson Disease: a Positron Emission Tomography (PET) Study | Motor Activation in Patients With Multi Systemic Atrophy and Comparison With Parkinson Disease and Dopaminergic Challenge | Multisystemic Atrophy | Radiation: H215O PET;Drug: Levodopa | University Hospital, Toulouse | NULL | Completed | 40 Years | 75 Years | Both | 38 | N/A | France |
| 1089 | NCT00203164 (ClinicalTrials.gov) | May 2002 | 13/9/2005 | Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients | A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy | Parkinson's Disease | Drug: rasagiline mesylate | Teva Pharmaceutical Industries | NULL | Completed | 30 Years | N/A | Both | 254 | Phase 3 | United States |
| 1090 | NCT00456586 (ClinicalTrials.gov) | April 2002 | 3/4/2007 | 12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa | A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy | Parkinson's Disease | Drug: KW-6002 (istradefylline) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 180 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1091 | NCT02248168 (ClinicalTrials.gov) | March 2002 | 22/9/2014 | Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease | Mirapex PMS Study Final Report | Parkinson Disease | Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 1449 | N/A | NULL |
| 1092 | NCT00456794 (ClinicalTrials.gov) | March 2002 | 3/4/2007 | 12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa | A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of Doses of 20 and 60 mg/Day Istradefylline as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 325 | Phase 2 | United States |
| 1093 | NCT00040404 (ClinicalTrials.gov) | March 2002 | 26/6/2002 | Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Parkinson's Disease | Parkinson Disease | Drug: CEP-1347 10mg;Drug: CEP1347 25mg;Drug: CEP-1347 50mg;Other: Placebo Comparator | Cephalon | H. Lundbeck A/S;The Parkinson Study Group | Terminated | 30 Years | N/A | Both | 806 | Phase 2;Phase 3 | United States;Canada;Puerto Rico |
| 1094 | NCT00032812 (ClinicalTrials.gov) | March 2002 | 3/4/2002 | The Role of Dopamine in Motor Learning in Healthy Subjects and Patients With Parkinson's Disease | Motor Memory: Study of the Role of Dopamine in Healthy Subjects and Patients With Parkinson's Disease Using PET and EEG | Parkinson Disease;Healthy | Drug: Raclopride | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 64 | N/A | United States |
| 1095 | NCT02231255 (ClinicalTrials.gov) | February 2002 | 2/9/2014 | Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease | Switch Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease | Parkinson Disease | Drug: Sifrol® | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 1216 | N/A | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1096 | NCT00407212 (ClinicalTrials.gov) | January 2002 | 30/11/2006 | A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease | Parkinson's Disease | Drug: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt) | Novartis | NULL | Completed | 30 Years | 80 Years | Both | 301 | Phase 1;Phase 2 | United States;Brazil;Canada;France;Germany;Italy;Netherlands;Portugal;United Kingdom |
| 1097 | NCT00036218 (ClinicalTrials.gov) | December 2001 | 8/5/2002 | Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease. | A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease. | Parkinson Disease | Drug: sumanirole;Drug: ropinirole | Pfizer | NULL | Completed | 30 Years | N/A | Both | 600 | Phase 3 | United States;Argentina;Mexico;Puerto Rico |
| 1098 | NCT00203177 (ClinicalTrials.gov) | October 2001 | 13/9/2005 | Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy. | A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy. | Parkinson's Disease | Drug: rasagiline mesylate;Drug: rasagiline mesylate 1.0 mg | Teva Pharmaceutical Industries | NULL | Completed | 30 Years | N/A | Both | 254 | Phase 3 | United States;Canada |
| 1099 | NCT00200525 (ClinicalTrials.gov) | July 2001 | 13/9/2005 | Continued Efficacy and Safety of Apomorphine in Patients With Late-Stage Parkinsons Disease | A Randomized, Placebo-Controlled Study of the Continued Efficacy and Safety of SC Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing-Off Effects Associated With Late-Stage PD After Apomorphine Use | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 60 | Phase 3 | NULL |
| 1100 | NCT00145171 (ClinicalTrials.gov) | February 2001 | 2/9/2005 | A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients. | Study of Orthostatic Changes Upon Apomorphine Dose Initiation in Late Stage Parkinson’s Disease Patients. A Dose Escalation Study With a Double-Blind Placebo-Controlled Efficacy Determination at 4 Mg. | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 56 | Phase 3 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1101 | NCT00203125 (ClinicalTrials.gov) | October 2000 | 13/9/2005 | A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study. | Sub-study to Evaluate the Effect of An Oral Dose of Tyramine in Subjects Completing 26 Weeks of Participation in PRESTO (TVP-1012/133) | Parkinson's Disease | Drug: rasagiline mesylate;Other: tyramine | Teva Pharmaceutical Industries | NULL | Completed | N/A | N/A | Both | 55 | Phase 3 | United States |
| 1102 | NCT00070928 (ClinicalTrials.gov) | September 2000 | 9/10/2003 | Valerian to Improve Sleep in Patients With Parkinson's Disease | Polysomnographic Assessment of Alternative Treatments for Sleep Disturbance in Parkinson's Disease | Insomnia;Parkinson's Disease | Drug: valerian | National Center for Complementary and Integrative Health (NCCIH) | NULL | Completed | 30 Years | 80 Years | Both | 80 | Phase 2 | United States |
| 1103 | NCT00036205 (ClinicalTrials.gov) | August 2000 | 8/5/2002 | Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease | Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease. | Parkinson Disease | Drug: sumanirole | Pfizer | NULL | Terminated | 30 Years | N/A | Both | 984 | Phase 3 | United States;Argentina;Colombia;Puerto Rico |
| 1104 | NCT02231294 (ClinicalTrials.gov) | July 2000 | 2/9/2014 | The Effect of Sifrol® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease | The Effect of SIFROL® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease Patients. | Parkinson Disease | Drug: Sifrol® | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 1464 | N/A | NULL |
| 1105 | NCT00203034 (ClinicalTrials.gov) | May 2000 | 13/9/2005 | Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations | A Multicenter, US and Canada, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study, for the Efficacy, Tolerability and Safety of Rasagiline Mesylate in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: rasagiline mesylate;Drug: 1.0 mg rasagiline mesylate;Other: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 30 Years | N/A | Both | 472 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1106 | NCT00761436 (ClinicalTrials.gov) | February 2000 | 26/9/2008 | Pilot Study of Safety and Efficacy of Spheramine | Stereotactic Intrastriatal Implantation of Spheramine in Advanced Parkinson's Disease Patients: A Pilot Study of Tolerability and Efficacy. | Parkinson's Disease | Biological: Spheramine (BAY86-5280) | Bayer | Titan Pharmaceuticals | Terminated | 40 Years | 70 Years | Both | 6 | Phase 2 | United States |
| 1107 | NCT00200512 (ClinicalTrials.gov) | September 1999 | 13/9/2005 | Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months | A Prospective, Randomized, Placebo-Controlled, Crossover Study of the Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing Off Effects Associated With Late Stage Parkinson's Disease | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 16 | Phase 2;Phase 3 | United Kingdom |
| 1108 | NCT00142545 (ClinicalTrials.gov) | July 1999 | 31/8/2005 | Long Term Safety and Efficacy of SC Apomorphine in Treatment of Off Episodes in Late-Stage Parkinson's Disease | Long-Term Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off” Episodes in Patients With On-Off” or Wearing-Off” Effects Associated With Late-Stage Parkinson’s Disease | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 800 | Phase 3 | United States |
| 1109 | NCT00001931 (ClinicalTrials.gov) | May 1999 | 31/7/2007 | Treatment of Parkinson's Disease With a Transdermal Skin Patch | Transdermal Application of Dopamine Agonist N-0923 in Parkinson's Disease | Parkinson Disease | Drug: N-0923 | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 20 | Phase 2 | United States |
| 1110 | NCT02177357 (ClinicalTrials.gov) | November 1998 | 24/6/2014 | Pramipexole in Untreated and Levodopa-treated Parkinson's Disease Patients | Pramipexole: Efficacy, Safety and Tolerability Study in Untreated and Levodopa-Treated Parkinson's Disease Patients, a Multinational Study | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | Both | 150 | Phase 3 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1111 | NCT02248220 (ClinicalTrials.gov) | October 1998 | 22/9/2014 | Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease | Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease | Parkinson Disease | Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 657 | N/A | NULL |
| 1112 | NCT02233023 (ClinicalTrials.gov) | June 1998 | 4/9/2014 | Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease | Matched Pair, Assessor Blinded, Open Label Clinical Trial to Assess the Ophthalmologic Safety of Long Term Oral Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease | Parkinson Disease | Drug: Pramipexole;Drug: Bromocriptine and other dopamine agonists | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 705 | Phase 4 | NULL |
| 1113 | NCT00004451 (ClinicalTrials.gov) | March 1998 | 18/10/1999 | Randomized Study of the Effects of Glucose on Cognition in Healthy Young and Elderly People and Parkinson's Disease Patients | Parkinson Disease | Drug: Glucose | National Institute of Mental Health (NIMH) | University of Virginia | Completed | 18 Years | N/A | Both | 120 | N/A | United States | |
| 1114 | NCT00226460 (ClinicalTrials.gov) | August 1997 | 23/9/2005 | Phase 2, Double-blind, Randomized, Controlled Multi-center Clinical Trial of the Safety and Efficacy of Transplanted Fetal Porcine Cells in Patients With Parkinson's Disease. | Parkinson's Disease | Drug: Fetal porcine cells, Neurocell-PD | Genzyme, a Sanofi Company | Diacrin/Genzyme Corporation LLC | Completed | 40 Years | 70 Years | Both | Phase 2 | United States | ||
| 1115 | NCT00203060 (ClinicalTrials.gov) | July 1997 | 13/9/2005 | Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa | A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Clinical Trial For The Efficacy, Tolerability And Safety Of Two Doses Of Rasagiline Mesylate In Early Parkinson's Disease (PD) Patients Not Treated With Levodopa | Parkinson's Disease | Drug: Rasagiline Mesylate;Drug: placebo | Teva Neuroscience, Inc. | NULL | Completed | 35 Years | N/A | Both | 404 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1116 | NCT00004826 (ClinicalTrials.gov) | October 1993 | 24/2/2000 | Study of Clozapine for the Treatment of Psychosis in Patients With Idiopathic Parkinson's Disease | Parkinson Disease | Drug: clozapine | Memorial Hospital of Rhode Island | NULL | Completed | N/A | N/A | Both | 60 | N/A | NULL | |
| 1117 | NCT00132626 (ClinicalTrials.gov) | September 1992 | 18/8/2005 | Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome | Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism | Parkinson's Disease;Parkinsonian Syndrome | Drug: [123I]ß-CIT and SPECT imaging | Institute for Neurodegenerative Disorders | Molecular NeuroImaging;National Institutes of Health (NIH) | Completed | 35 Years | N/A | All | 500 | Phase 2 | NULL |
| 1118 | EUCTR2016-000657-12-AT (EUCTR) | 17/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden | |||
| 1119 | EUCTR2008-004447-11-DE (EUCTR) | 17/10/2008 | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: | Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2b | Germany;Italy;United Kingdom | |||
| 1120 | EUCTR2010-022200-46-DE (EUCTR) | 13/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Pakinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Latvia;Germany | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1121 | EUCTR2006-006907-35-DE (EUCTR) | 30/01/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3B | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | |||
| 1122 | EUCTR2006-001755-36-DE (EUCTR) | 15/08/2006 | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Germany;Sweden | ||||
| 1123 | JPRN-JapicCTI-121954 | Phase III study on FPF1100NW monotherapy | Randomized, double-blind, placebo-controlled study on FPF1100NW monotherapy with early Parkinson's disease patients (Phase III study) | Early Parkinson's disease | Intervention name : FPF1100NW INN of the intervention : Selegiline Dosage And administration of the intervention : oral Control intervention name : null | FP Pharmaceutical Corp. | NULL | 20 | 74 | BOTH | 280 | Phase 3 | NULL | |||
| 1124 | JPRN-JapicCTI-070377 | 28/03/2007 | Double-blind, parallel-group confirmatory study of AD-810N (zonisamide) in patients with Parkinson's disease | Double-blind, parallel-group confirmatory study of AD-810N (zonisamide) in patients with Parkinson's disease | Parkinson's disease | Intervention name : AD-810N (zonisamide) Dosage And administration of the intervention : oral | Dainippon Sumitomo Pharma Co., Ltd. | NULL | 20 | 74 | BOTH | Phase 3 | NULL | |||
| 1125 | JPRN-JapicCTI-101020 | Phase II study on FPF1100NW monotherapy | Study on FPF1100NW monotherapy with early Parkinson's disease patients (Phase II study) | Parkinson's disease | Intervention name : FPF1100NW INN of the intervention : Selegiline Dosage And administration of the intervention : oral Control intervention name : null | FP Pharmaceutical Corp. | NULL | 20 | 74 | BOTH | 90 | Phase 2 | NULL | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1126 | EUCTR2008-005492-94-DE (EUCTR) | 11/08/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Thailand;Chile;Colombia;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand | ||||
| 1127 | EUCTR2011-002073-30-DE (EUCTR) | 20/09/2011 | Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 12-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 63 | France;United States;Hungary;Canada;Spain;Germany;Italy | ||||
| 1128 | EUCTR2009-014341-84-DE (EUCTR) | 07/10/2009 | Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms. | Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms. | idiopathic Parkinson's disease MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 2mg/24h(10cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 4 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 4mg/24h (20cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 6 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 6mg/24h (30cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 8mg/24h (40cm2) INN or Proposed INN: rotigotine | Schwarz Pharma Deutschland GmbH, UCB Group | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04660539 (ClinicalTrials.gov) | January 11, 2021 | 24/11/2020 | A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica Spectrum Disorder | Drug: satralizumab;Drug: azathioprine (AZA);Drug: mycophenolate mofetil (MMF);Drug: oral corticosteroids | Hoffmann-La Roche | NULL | Not yet recruiting | 18 Years | N/A | All | 127 | Phase 3 | United States;Bulgaria;Canada;Croatia;Germany;Hungary;Italy;Japan;Korea, Republic of;Malaysia;Poland;Puerto Rico;Romania;Spain;Taiwan;Turkey;Ukraine;United Kingdom |
| 2 | NCT04601233 (ClinicalTrials.gov) | January 4, 2021 | 2/10/2020 | Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis | Testosterone TReatment for Erectile Dysfunction in Male Multiple Sclerosis Patients With Low Testosterone (TTRED-MS Study) | Multiple Sclerosis;Erectile Dysfunction;Testosterone Deficiency | Drug: XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector | Tulane University | Louisiana State University Health Sciences Center in New Orleans;Antares Pharma Inc. | Not yet recruiting | 18 Years | N/A | Male | 20 | Phase 4 | United States |
| 3 | NCT04586023 (ClinicalTrials.gov) | December 26, 2020 | 8/10/2020 | Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS) | A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: fenebrutinib;Drug: teriflunomide;Drug: placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 55 Years | All | 734 | Phase 3 | United States |
| 4 | NCT04586010 (ClinicalTrials.gov) | December 18, 2020 | 8/10/2020 | A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS) | A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: fenebrutinib;Drug: teriflunomide;Drug: placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 55 Years | All | 734 | Phase 3 | United States |
| 5 | EUCTR2019-003919-53-GB (EUCTR) | 17/12/2020 | 26/11/2020 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH OCRELIZUMAB IN ADULT PATIENTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary Progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 RO7010939 Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Denmark;Australia;Peru;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT04655222 (ClinicalTrials.gov) | December 1, 2020 | 30/11/2020 | Study to Investigate Pregnancy Outcomes in Female Participants Exposed to Subcutaneous (SC) Peginterferon Beta-1a and Intramuscular (IM) Interferon Beta-1a Reported in a German Participant Support Program | Non-interventional Safety Study to Investigate Pregnancy Outcomes in Female Patients Exposed to SC Peginterferon Beta-1a and IM Interferon Beta-1a Reported in a German Patient Support Program | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon Beta Therapy | Biogen | NULL | Not yet recruiting | 18 Years | N/A | Female | 8544 | NULL | |
| 7 | NCT04625153 (ClinicalTrials.gov) | December 2020 | 6/11/2020 | RC18 in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II Trial | RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II Trial | Multiple Sclerosis, Relapsing-Remitting | Biological: RC18 160mg;Biological: RC18 240mg | RemeGen | NULL | Not yet recruiting | 18 Years | 55 Years | All | 18 | Phase 2 | NULL |
| 8 | NCT04657666 (ClinicalTrials.gov) | December 2020 | 11/11/2020 | Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients With Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients With Multiple Sclerosis | Spasticity in Participants With Multiple Sclerosis | Drug: Nabiximols;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Not yet recruiting | 18 Years | N/A | All | 52 | Phase 3 | NULL |
| 9 | NCT04640818 (ClinicalTrials.gov) | November 30, 2020 | 18/11/2020 | Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy | Safety and Efficacy of a Therapy With Cladribine Following a Treatment With Anti CD20 Compounds in Relapsing Multiple Sclerosis Patients: a Pilot Study | Multiple Sclerosis | Drug: Cladribine Oral Tablet;Drug: Rituximab;Drug: Ocrelizumab | Claudio Gobbi | Merck AG Switzerland | Not yet recruiting | 18 Years | 80 Years | All | 45 | Switzerland | |
| 10 | EUCTR2019-004857-10-FI (EUCTR) | 20/11/2020 | 03/11/2020 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing multiple sclerosis (RMS) MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Genentech, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 734 | Phase 3 | United States;France;Finland;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT04356339 (ClinicalTrials.gov) | November 15, 2020 | 19/4/2020 | US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage and Patient Reported Outcomes Via the myBETAapp in Medical Care of Patients With Multiple Sclerosis Treated With BETASERON Using BETACONNECT Autoinjector | US PROmyBETAapp2.0: Ascertaining Medication Usage and Patient-reported Outcomes (PROs) Via the myBETAapp™ in Patients With Multiple Sclerosis Treated With BETASERON® Using BETACONNECT™ Autoinjector | Multiple Sclerosis | Drug: Interferon-beta-1b (BETASERON, BAY 86-5046) | Bayer | NULL | Not yet recruiting | 18 Years | N/A | All | 200 | United States | |
| 12 | NCT04150549 (ClinicalTrials.gov) | November 2020 | 11/10/2019 | FMT for MS Patients | Fecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized Trial | Multiple Sclerosis | Biological: Fecal Microbial Transplants | Lawson Health Research Institute | NULL | Not yet recruiting | 18 Years | 55 Years | All | 34 | Phase 2 | NULL |
| 13 | NCT04593927 (ClinicalTrials.gov) | October 30, 2020 | 14/10/2020 | Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients | Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients (Prevention of Relapse and Delay of Progression of Physical Disability in Secondary Progressive Multiple Sclerosis) | Secondary Progressive Multiple Sclerosis (SPMS) | Drug: Mayzent | Novartis Pharmaceuticals | NULL | Not yet recruiting | N/A | 99 Years | All | 330 | NULL | |
| 14 | NCT04544449 (ClinicalTrials.gov) | October 26, 2020 | 4/9/2020 | A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis | A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis. | Multiple Sclerosis, Primary Progressive | Drug: fenebrutinib;Drug: ocrelizumab;Drug: placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 946 | Phase 3 | United States;Canada;France;Argentina;Australia;Austria;Belgium;Brazil;Czechia;Denmark;Germany;Greece;Hungary;Israel;Italy;Mexico;New Zealand;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom |
| 15 | NCT04626921 (ClinicalTrials.gov) | October 22, 2020 | 30/10/2020 | A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis | VISIONARY-MS LTE: A Multi-Center, Open-Label Long-Term Extension Study Assessing the Safety, Efficacy, Tolerability, and Pharmacokinetics of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: CNM-Au8 | Clene Nanomedicine | George Clinical | Enrolling by invitation | 18 Years | 55 Years | All | 150 | Phase 2;Phase 3 | Australia |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2019-001829-26-DE (EUCTR) | 19/10/2020 | 08/01/2020 | A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Soliris Product Name: Soliris Product Code: Soliris INN or Proposed INN: ECULIZUMAB Other descriptive name: h5G1.1-mAb | Alexion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 2;Phase 3 | United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of | ||
| 17 | NCT04486716 (ClinicalTrials.gov) | October 19, 2020 | 23/7/2020 | A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis | A Single-arm, Prospective, Multi-center Study to Explore Maintained Efficacy With Ofatumumab Therapy in Patients With Relapsing Multiple Sclerosis Who Discontinue Intravenously Delivered Anti-CD20 Monoclonal Antibody (aCD20 mAb) Therapy (OLIKOS) | Relapsing Multiple Sclerosis | Drug: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 100 | Phase 3 | United States |
| 18 | NCT04480853 (ClinicalTrials.gov) | October 12, 2020 | 17/7/2020 | Safety and Efficacy Study of Fingolimod in Taiwanese Adults (= 20years) With Relapsing Remitting Multiple Sclerosis | A 12-month, Prospective, Multi-center Post-authorization Commitment (PAC) Study Monitoring Safety in Adult Patients With Relapsing-remitting Multiple Sclerosis Newly Initiated on Gilenya (Fingolimod) in Taiwan (SPRING) | Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Recruiting | 20 Years | N/A | All | 30 | Phase 4 | Taiwan |
| 19 | NCT04203498 (ClinicalTrials.gov) | October 1, 2020 | 17/12/2019 | Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis | A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients With Spasticity Due to Multiple Sclerosis | Multiple Sclerosis (MS) | Drug: Nabiximols;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Recruiting | 18 Years | N/A | All | 446 | Phase 3 | Poland |
| 20 | NCT04602390 (ClinicalTrials.gov) | October 2020 | 5/10/2020 | Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis | A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis;Relapsing Remitting Multiple Sclerosis | Drug: ANK-700;Drug: Placebo | Anokion SA | NULL | Not yet recruiting | 18 Years | 55 Years | All | 33 | Phase 1 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2019-001341-40-AT (EUCTR) | 10/09/2020 | 07/07/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 22 | NCT04540861 (ClinicalTrials.gov) | September 1, 2020 | 31/8/2020 | Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active Disease | Managed Access Program (MAP) to Provide Access to Siponimod Treatment for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With no Satisfactory Alternative Treatment | Multiple Sclerosis | Drug: Siponimod | Novartis Pharmaceuticals | NULL | Available | 18 Years | N/A | All | NULL | ||
| 23 | NCT02912897 (ClinicalTrials.gov) | September 2020 | 13/9/2016 | Trial to Assess the Safety and Feasibility of Adoptive Cell Therapy With Autologous EBV-specific Cytotoxic T Lymphocytes (CTL) in Patients With a First Clinical Episode Highly Suggestive of Multiple Sclerosis | An Open Single-center, Phase I Proof of Concept Trial to Assess the Safety and Feasibility of Adoptive Cell Therapy With Autologous EBV-specific Cytotoxic T Lymphocytes (CTL) in Patients With a First Clinical Episode Highly Suggestive of Multiple Sclerosis | Multiple Sclerosis | Biological: Cellular therapy with EBV specific autologous CTL infusion | Nantes University Hospital | NULL | Not yet recruiting | 18 Years | 45 Years | All | 7 | Phase 1 | France |
| 24 | NCT04510220 (ClinicalTrials.gov) | August 2020 | 31/7/2020 | 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis | Open-label, Observational, Prospective, 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Ofatumumab;Drug: [F-18]PBR06 | Brigham and Women's Hospital | Novartis | Not yet recruiting | 18 Years | 60 Years | All | 10 | Phase 3 | United States |
| 25 | NCT04377555 (ClinicalTrials.gov) | July 30, 2020 | 1/5/2020 | Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) Before and During Treatment With Ocrelizumab | An Open-Label, Multicenter Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab | Multiple Sclerosis, Relapsing | Drug: Ocrelizumab | Genentech, Inc. | NULL | Recruiting | 18 Years | 65 Years | All | 150 | Phase 4 | United States;Puerto Rico |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT04353492 (ClinicalTrials.gov) | July 14, 2020 | 16/4/2020 | An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab | A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy | Relapsing Multiple Sclerosis | Biological: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 60 Years | All | 550 | Phase 3 | United States;Australia;Belgium;Bulgaria;Czechia;Germany;Greece;Hungary;Portugal;Russian Federation;Slovakia;Spain;Turkey |
| 27 | NCT04458688 (ClinicalTrials.gov) | July 2020 | 30/6/2020 | Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis | Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) Study | Multiple Sclerosis, Relapsing-Remitting | Other: Observation of Ocrelizumab as Treatment in RRMS Patients | Wayne State University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 80 | NULL | |
| 28 | NCT04480307 (ClinicalTrials.gov) | June 17, 2020 | 10/7/2020 | Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis | A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (RMS) | Multiple Sclerosis | Drug: temelimab 18 mg/kg;Drug: temelimab 36 mg/kg;Drug: temelimab 54 mg/kg;Drug: Placebo | GeNeuro Innovation SAS | NULL | Recruiting | 18 Years | 55 Years | All | 40 | Phase 2 | Sweden |
| 29 | EUCTR2019-001341-40-PT (EUCTR) | 15/06/2020 | 31/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Austria;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 30 | EUCTR2019-001341-40-BG (EUCTR) | 12/06/2020 | 07/05/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2019-003352-37-NL (EUCTR) | 11/06/2020 | 24/02/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 32 | NCT04410965 (ClinicalTrials.gov) | May 20, 2020 | 28/5/2020 | Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese Relapsing Multiple Sclerosis Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks | Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks | Multiple Sclerosis | Drug: TERIFLUNOMIDE | Sanofi | NULL | Recruiting | 18 Years | 55 Years | All | 80 | Phase 4 | China |
| 33 | EUCTR2019-001341-40-GR (EUCTR) | 20/05/2020 | 10/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 34 | EUCTR2019-004822-15-SE (EUCTR) | 18/05/2020 | 17/01/2020 | A Clinical Trial Examining the Effects of Temelimab Following Rituximab Treatment in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients with Relapsing Forms of Multiple Sclerosis (RMS) - ProTEct-MS | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab | GeNeuro Innovation SAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Sweden | ||
| 35 | EUCTR2019-003352-37-DE (EUCTR) | 11/05/2020 | 06/01/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2019-001341-40-CZ (EUCTR) | 07/05/2020 | 11/02/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom | ||
| 37 | EUCTR2018-000620-34-DE (EUCTR) | 06/05/2020 | 08/11/2019 | Imatinib treatment for Multiple Sclerosis (MS) Relapses | Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS | Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: IMATINIB MESILATE INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Department of Clinical Neuroscience, Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Germany;Sweden | ||
| 38 | EUCTR2019-001341-40-HU (EUCTR) | 29/04/2020 | 11/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 39 | EUCTR2019-001341-40-BE (EUCTR) | 29/04/2020 | 17/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 40 | EUCTR2019-001341-40-ES (EUCTR) | 24/04/2020 | 07/05/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy - ARTIOS | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Farmacéutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2019-002623-14-PL (EUCTR) | 15/04/2020 | 21/01/2020 | A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosis | A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis | Symptomatic relief of spasticity in Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 446 | Phase 3 | United States;Czech Republic;Poland;Romania;United Kingdom | ||
| 42 | EUCTR2019-003127-38-NL (EUCTR) | 09/04/2020 | 09/04/2020 | Research on the effect of add-on high dosage simvastatin treatment on progression in MS patients treated with ocrelizumab and natalizumab. | Efficacy of add-on high dose simvastatin on markers for disease progression in MS patients treated with ocrelizumab and natalizumab (SIMSON), a phase II clinical trial. - SIMSON trial | Multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Simvastatin INN or Proposed INN: SIMVASTATIN Other descriptive name: Simvastatine | VUmc Neurology Department | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Netherlands | ||
| 43 | NCT04227470 (ClinicalTrials.gov) | March 31, 2020 | 21/11/2019 | A Study of HBM9161 in NMOSD Patients | Safety, Tolerability, Pharmacodynamics and Efficacy of HBM9161 Weekly Subcutaneous Administration in Patients With Neuromyelitis Optica Spectrum Disorders (NMOSD) in China | NMO Spectrum Disorder | Drug: HBM9161 Injection | Harbour BioMed (Guangzhou) Co. Ltd. | NULL | Recruiting | 18 Years | N/A | All | 12 | Phase 1 | China |
| 44 | EUCTR2019-003352-37-AT (EUCTR) | 27/03/2020 | 13/02/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 45 | EUCTR2019-001549-42-GB (EUCTR) | 27/03/2020 | 03/02/2020 | Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MS | A multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS | Highly active relapsing remitting multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cyclophosphamide INN or Proposed INN: Cyclophosphamide monohydrate INN or Proposed INN: Cyclophosphamide monohydrate Product Name: Filgrastim INN or Proposed INN: Filgrastim Trade Name: Thymoglobuline Product Name: Thymoglobuline INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin Trade Name: Alemtuzumab Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Product Name: Lenograstim INN or Proposed INN: Lenograstim Trade Name: Ocrelizumab Product Name: Ocrelizumab | Sheffield Teaching Hospitals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 198 | Phase 3 | United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | EUCTR2017-001313-93-DE (EUCTR) | 27/03/2020 | 12/02/2020 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United Arab Emirates;Morocco;Costa Rica;Spain;Lebanon;Ireland;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Germany;Algeria | ||
| 47 | EUCTR2019-002623-14-CZ (EUCTR) | 17/03/2020 | 19/12/2019 | A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosis | A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis | Symptomatic relief of spasticity in Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray (non-marketed) INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 446 | Phase 3 | United States;Czech Republic;Poland;Romania;United Kingdom | ||
| 48 | EUCTR2019-002625-29-GB (EUCTR) | 16/03/2020 | 18/06/2020 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis - Study in MS patient Naïve to treatment with Nabiximols | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray Product Name: Sativex Oromucosal Spray INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 3 | Poland;United Kingdom | ||
| 49 | EUCTR2019-003352-37-ES (EUCTR) | 25/02/2020 | 14/01/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | |||
| 50 | EUCTR2019-002623-14-GB (EUCTR) | 24/02/2020 | 18/03/2020 | A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosis | A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis - Nabiximols Oromucosal Spray as Add-on Therapy in Patients with MS | Symptomatic relief of spasticity in Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: UK: Sativex Oromucosal Spray Product Name: UK: Sativex Oromucosal Spray INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 446 | Phase 3 | United States;Czech Republic;Poland;Romania;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT04242056 (ClinicalTrials.gov) | February 20, 2020 | 21/1/2020 | To Study the Pathophysiological Features of Multiple Sclerosis | To Study the Pathophysiological Features of Multiple Sclerosis: Combined Multi-modalities of Amyloid and Tau Images Associated With Serum Neurofilament Light Chain Levels | Multiple Sclerosis;Neurofilament Light Chain;Glial Fibrillary Acidic Protein | Drug: 18F-PM-PBB3 | Chang Gung Memorial Hospital | NULL | Not yet recruiting | 20 Years | 70 Years | All | 38 | Phase 1;Phase 2 | NULL |
| 52 | NCT04175834 (ClinicalTrials.gov) | February 5, 2020 | 22/11/2019 | Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab | Comparing the Risk and Severity of Infusion-Related Reactions in Patients Premedicated With Cetirizine Versus Diphenhydramine Prior to Ocrelizumab Infusions | Multiple Sclerosis;Infusion Reaction | Drug: antihistamine | Providence Health & Services | Genentech, Inc. | Recruiting | 18 Years | 70 Years | All | 52 | Phase 3 | United States |
| 53 | NCT04267185 (ClinicalTrials.gov) | February 4, 2020 | 16/1/2020 | A Dyadic Approach for Promoting Physical Activity Among People With MS and Their Support Partners | Physical Activity Together for MS (PAT-MS): Pilot Study of a Dyadic Rehabilitation Intervention for People With Moderate-to-Severe Multiple Sclerosis Disability and Their Family Caregivers | Multiple Sclerosis | Behavioral: Physical Activity Together for PwMS and their CGs (PAT-MS) | University of Ottawa | The Ottawa Hospital;Consortium of Multiple Sclerosis Centers | Active, not recruiting | 18 Years | N/A | All | 40 | N/A | Canada |
| 54 | EUCTR2019-003352-37-DK (EUCTR) | 15/01/2020 | 19/12/2019 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 55 | NCT04155424 (ClinicalTrials.gov) | January 14, 2020 | 5/11/2019 | A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients With Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Drug: Eculizumab | Alexion Pharmaceuticals | NULL | Recruiting | 2 Years | 17 Years | All | 15 | Phase 2;Phase 3 | United States;Japan;Korea, Republic of;Spain;Canada;Germany;Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | EUCTR2019-002625-29-PL (EUCTR) | 14/01/2020 | 21/11/2019 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 3 | Poland;United Kingdom | ||
| 57 | EUCTR2018-000001-23-CZ (EUCTR) | 13/01/2020 | 16/08/2018 | Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosis | A phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS | Symptomatic relief of spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dronabinol 25 mg/ml, oral drops Product Code: BX-1 INN or Proposed INN: Dronabinol Other descriptive name: Dronabinol | Bionorica SE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 548 | Phase 3 | Hungary;Czech Republic;Spain | ||
| 58 | EUCTR2019-000069-19-HR (EUCTR) | 24/12/2019 | 20/02/2020 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | |||
| 59 | EUCTR2019-002566-13-NL (EUCTR) | 19/12/2019 | 29/10/2019 | Personalizing the treatment with natalizumab in patients with multiple sclerosis | Personalized extended interval dosing of natalizumab in relapsing remitting multiple sclerosis - NEXT-MS | Relapsing remitting multiple sclerosis MedDRA version: 20.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Amsterdam University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 4 | Netherlands | |||
| 60 | EUCTR2019-001829-26-ES (EUCTR) | 18/12/2019 | 06/11/2019 | A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Alexion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 2;Phase 3 | United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT04201262 (ClinicalTrials.gov) | December 13, 2019 | 11/12/2019 | An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Biological: Ravulizumab | Alexion Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 55 | Phase 3 | United States;Australia;Austria;Canada;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Poland;Spain |
| 62 | NCT04211740 (ClinicalTrials.gov) | December 6, 2019 | 17/12/2019 | Phase II Clinical Trial of OCH-NCNP1 | Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive | Drug: OCH-NCNP1;Drug: Placebo | National Center of Neurology and Psychiatry, Japan | NULL | Enrolling by invitation | 20 Years | 65 Years | All | 30 | Phase 2 | Japan |
| 63 | EUCTR2019-000069-19-AT (EUCTR) | 20/11/2019 | 06/06/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck, S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Serbia;Estonia;Morocco;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 64 | EUCTR2019-003001-94-SK (EUCTR) | 06/11/2019 | 13/09/2019 | Use of GLP-1 analogs in the treatment of multiple sclerosis | Use of GLP-1 analogs in the treatment of multiple sclerosis - MSGLP | Our hypothesis is that patients with MS have a disorder of energy metabolism in neurons and glial cells of the CNS, contributing to the development and progression of demyelinating foci and neurodegeneration, and manifested by insulin resistance in both peripheral tissues and the CNS. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere. Product Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere | Lekárska fakulta UK Bratislava | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Slovakia | ||
| 65 | NCT04146285 (ClinicalTrials.gov) | November 5, 2019 | 26/9/2019 | A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders | A Phase I Clinical Trial of BAT4406F Injection on the Safety, Tolerability, and Pharmacokinetics in Patients With Neuromyelitis Optica Spectrum Disorders | Neuromyelitis Optica Spectrum Disorders | Drug: BAT4406F | Bio-Thera Solutions | NULL | Not yet recruiting | 18 Years | 65 Years | All | 48 | Phase 1 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | JPRN-JapicCTI-205119 | 15/10/2019 | 20/01/2020 | A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients | A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients | neuromyelitis optica(NMO), neuromyelitis optica spectrum disorders (NMOSD) | Intervention name : SA237 INN of the intervention : satralizumab Dosage And administration of the intervention : 120 mg subcutaneously at Weeks 0, 2 and 4 and every 4 weeks thereafter Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Chugai Pharmaceutical Co., Ltd. | F. Hoffmann-La Roche Ltd | complete | 12 | 74 | BOTH | 30 | NA | Japan |
| 67 | EUCTR2019-000069-19-PT (EUCTR) | 14/10/2019 | 13/05/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | Romania;Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 68 | NCT04129736 (ClinicalTrials.gov) | October 10, 2019 | 15/10/2019 | Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis | Determination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily. | Multiple Sclerosis, Pharmacokinetics | Drug: Teriflunomide 14 MG | Jan Lycke | NULL | Recruiting | 18 Years | 65 Years | All | 20 | Phase 4 | Sweden |
| 69 | NCT04115488 (ClinicalTrials.gov) | October 1, 2019 | 10/9/2019 | Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® | Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) | Relapsing-Remitting Multiple Sclerosis (RRMS) | Biological: Intravenous (IV) infusions | Polpharma Biologics S.A. | NULL | Active, not recruiting | 18 Years | 60 Years | All | 260 | Phase 3 | Belarus;Croatia;Georgia;Moldova, Republic of;Poland;Serbia;Ukraine |
| 70 | NCT04144257 (ClinicalTrials.gov) | October 2019 | 28/10/2019 | Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue | Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue | Multiple Sclerosis | Drug: [F-18]PBR06;Drug: [C-11]Methylreboxetine | Brigham and Women's Hospital | United States Department of Defense | Not yet recruiting | 18 Years | 60 Years | All | 12 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2017-001362-25-NL (EUCTR) | 30/09/2019 | 10/09/2019 | Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. | Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS | Relapsing remitting multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Helse Bergen HF, Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | Denmark;Netherlands | |||
| 72 | EUCTR2018-004751-20-HR (EUCTR) | 18/09/2019 | 02/12/2019 | A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis | Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: PB006 INN or Proposed INN: NATALIZUMAB Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB | Polpharma Biologics S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 3 | Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of | ||
| 73 | NCT04002934 (ClinicalTrials.gov) | September 10, 2019 | 25/6/2019 | Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis | A Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Delayed-Start Trial to Assess the Efficacy, Safety, and Tolerability of Bazedoxifene Acetate (BZA) as a Remyelinating Agent in Patients With Multiple Sclerosis | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Bazedoxifene Acetate | Riley Bove, MD | NULL | Recruiting | 40 Years | 65 Years | Female | 50 | Phase 2 | United States |
| 74 | EUCTR2019-000069-19-PL (EUCTR) | 08/09/2019 | 27/06/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | Lithuania;United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 75 | EUCTR2019-000069-19-BG (EUCTR) | 05/09/2019 | 04/06/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | EUCTR2019-000169-19-GB (EUCTR) | 03/09/2019 | 05/06/2019 | Clinical trial to determine the effect of Famciclovir on Epstein Barr virus levels in the saliva of patients with Multiple Sclerosis. | Clinical trial to determine the effect of Famciclovir on Epstein-Barr virus activity as measured by EBV shedding in saliva of patients with Multiple Sclerosis. - Famciclovir in Multiple Sclerosis | Epstein Barr virus infection in people with multiple sclerosis. MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10014077;Term: EBV infection;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Virus Diseases [C02] | Trade Name: Famciclovir Product Name: Famciclovir INN or Proposed INN: Famciclovir Other descriptive name: 2-(2-(2-Amino-9H-purin-9-yl)ethyl)-1,3-propanediol diacetate ester | Queen Mary University London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United Kingdom | ||
| 77 | EUCTR2019-000069-19-LT (EUCTR) | 27/08/2019 | 10/06/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 78 | EUCTR2019-000069-19-ES (EUCTR) | 23/08/2019 | 04/07/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | |||
| 79 | NCT04221191 (ClinicalTrials.gov) | August 19, 2019 | 6/1/2020 | Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP | Study on the Dimethyl Fumarate (DMF, Tecfidera®) Persistence of Remitting-relapsing Multiple Sclerosis (RR-MS) Patients Included in the French Patient Support Program (PSP) OroSEP | Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl Fumarate;Other: PSP | Biogen | NULL | Recruiting | 18 Years | 55 Years | All | 350 | France | |
| 80 | NCT03961204 (ClinicalTrials.gov) | August 15, 2019 | 22/5/2019 | Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for Multiple Sclerosis (MS) | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Multiple Sclerosis | Drug: Cladribine | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Recruiting | 18 Years | 65 Years | All | 727 | Phase 4 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;Italy;Korea, Republic of;Lithuania;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Tunisia;Ukraine;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | EUCTR2019-000069-19-SE (EUCTR) | 14/08/2019 | 10/05/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 82 | NCT03972306 (ClinicalTrials.gov) | August 12, 2019 | 29/5/2019 | A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis | A Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple Sclerosis | Multiple Sclerosis (MS) | Drug: Ocrelizumab;Drug: rHuPH20 | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 135 | Phase 1 | United States |
| 83 | JPRN-JapicCTI-194838 | 31/7/2019 | 02/07/2019 | Investigation for immune response against JC virus in Multiple Sclerosis patients on treatment with fingolimod | A 18-month, multicenter, two-cohort, prospective, observational study to investigate immune response against JC virus in Multiple Sclerosis patients on treatment with 0.5 mg fingolimod (FTY720) | Multiple Sclerosis | Intervention name : Gilenya / Imusera INN of the intervention : Fingolimod Dosage And administration of the intervention : 0.5mg/day Fingolimod orally Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Novartis Pharma K.K. | Mitsubishi Tanabe Pharma Corporation | recruiting | 18 | BOTH | 280 | NA | Japan | |
| 84 | NCT03933202 (ClinicalTrials.gov) | July 22, 2019 | 29/4/2019 | A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) | Cladribine Tablets: Observational Evaluation of Effectiveness and Patient-Reported Outcomes (PROs) in Suboptimally Controlled Patients Previously Taking Oral or Infusion Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (MASTER-2) | Multiple Sclerosis | Drug: Cladribine Tablets | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Recruiting | 18 Years | N/A | All | 250 | United States | |
| 85 | EUCTR2018-004751-20-PL (EUCTR) | 22/07/2019 | 25/04/2019 | A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis | Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: PB006 INN or Proposed INN: NATALIZUMAB Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB | Polpharma Biologics S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 3 | Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | EUCTR2019-000069-19-CZ (EUCTR) | 12/07/2019 | 07/05/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Serbia;Estonia;Morocco;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 87 | NCT03656627 (ClinicalTrials.gov) | June 27, 2019 | 31/8/2018 | Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis | Drug: Nivolumab | Alliance Foundation Trials, LLC. | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 72 | Phase 1 | United States |
| 88 | EUCTR2019-000069-19-EE (EUCTR) | 17/06/2019 | 22/05/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | |||
| 89 | NCT03887065 (ClinicalTrials.gov) | June 15, 2019 | 10/3/2019 | Magnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinically Patients | Magnetic Resonance Imaging 12 Day Study for Multiple Sclerosis/Clinically Isolated Syndrome Trial of JM-4 Novel Human Peptide | Multiple Sclerosis | Drug: JM-4 | Cook, Stuart, MD | NULL | Not yet recruiting | 18 Years | 55 Years | All | 15 | Early Phase 1 | NULL |
| 90 | NCT04056897 (ClinicalTrials.gov) | June 7, 2019 | 12/8/2019 | Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis | International Multicenter, Randomized, Double-blind, Double-masked, Placebo-controlled Study of the Efficacy and Safety of BCD-132 Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: BCD-132, 125 mg;Drug: Teriflunomide;Drug: Placebo;Biological: BCD-132, 500 mg | Biocad | NULL | Recruiting | 18 Years | 60 Years | All | 270 | Phase 2 | Russian Federation |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | NCT04203017 (ClinicalTrials.gov) | June 1, 2019 | 30/10/2019 | Fecal Microbiota Transplantation After Autologous HSCT in Patients With Multiple Sclerosis | Allogeneic Fecal Microbiota Transplantation as a Consolidation Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: allogeneic fecal microbiota | St. Petersburg State Pavlov Medical University | NULL | Recruiting | 18 Years | 55 Years | All | 20 | Phase 1 | Russian Federation |
| 92 | NCT03933215 (ClinicalTrials.gov) | May 21, 2019 | 29/4/2019 | A Study of Suboptimally Controlled Participants Previously Taking Injectable Disease-modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) | Cladribine Tablets: Observational Evaluation of Effectiveness and Patient-Reported Outcomes (PROs) in Suboptimally Controlled Patients Previously Taking Injectable Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (CLICK-MS) | Multiple Sclerosis | Drug: Cladribine Tablets | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Recruiting | 18 Years | N/A | All | 136 | United States | |
| 93 | NCT03816345 (ClinicalTrials.gov) | April 4, 2019 | 24/1/2019 | Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Neoplasm | Biological: Nivolumab | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 264 | Phase 1 | United States |
| 94 | NCT03025269 (ClinicalTrials.gov) | April 2, 2019 | 16/1/2017 | Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple Sclerosis | Effect of Ocrelizumab on Gray Matter Pathology, Leptomeningeal Inflammation and Cognitive Dysfunction in Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | University at Buffalo | NULL | Enrolling by invitation | 18 Years | 60 Years | All | 30 | United States | |
| 95 | NCT03710655 (ClinicalTrials.gov) | April 2019 | 6/10/2018 | Evaluate Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and Quality of Life in MS Patients | Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and QOL in MS Patients | Multiple Sclerosis | Drug: Apitox - pure honeybee toxin;Drug: Placebo | Apimeds, Inc. | NULL | Unknown status | 18 Years | 65 Years | All | 468 | Phase 3 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | NCT03856619 (ClinicalTrials.gov) | March 27, 2019 | 25/2/2019 | To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis | A Single Arm Phase IV Clinical Trial to Describe the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: TERIFLUNOMIDE HMR1726 | Sanofi | NULL | Recruiting | 18 Years | N/A | All | 193 | Phase 4 | India |
| 97 | NCT03283397 (ClinicalTrials.gov) | March 26, 2019 | 12/9/2017 | A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of EK-12 in Patients With RRMS | A Phase IIIb, Multi-center, International, Randomized, Assessor-blind, Active-controlled Parallel Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Neuropeptide Combination of Metenkefalin and Tridecactide (EK-12) in Comparison to Interferon Beta-1a (REBIF®) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Drug: EK-12;Drug: INF beta-1a | Bosnalijek D.D | MonitorCRO | Recruiting | 18 Years | 55 Years | All | 400 | Phase 3 | Turkey |
| 98 | NCT03945006 (ClinicalTrials.gov) | March 25, 2019 | 8/5/2019 | Balance, Trunk Impairment and Fear of Falling in Multiple Sclerosis Patients With Incontinence | An Investigation of Balance, Trunk Impairment, and Fear of Falling in Multiple Sclerosis Patients With Incontinence | Multiple Sclerosis;Physical Therapy;Incontinence | Other: Incontinence Severity;Other: Balance;Other: Trunk impairment;Other: Fear of falling | Ankara Yildirim Beyazit University | NULL | Completed | 24 Years | 58 Years | All | 36 | Turkey | |
| 99 | NCT03808142 (ClinicalTrials.gov) | February 20, 2019 | 10/1/2019 | PROmyBETAappGame: a Study to Learn More About the Medication Usage & Patient Reported Outcomes Via the myBETAapp and to Find Out More About the Usage of Game Principles and Game Design Elements (Gamification) in Medical Care of Patients With Multiple Sclerosis Treated With Betaferon | PROmyBETAappGame: Ascertaining Medication Usage & Patient Reported Outcomes Via the myBETAapp and Exploring Gamification in Patients With Multiple Sclerosis Treated With Betaferon | Multiple Sclerosis | Other: myBETAapp;Other: PEAK;Drug: Betaferon, BAY 86-5046;Device: BETACONNECT | Bayer | NULL | Completed | 18 Years | N/A | All | 79 | Germany | |
| 100 | NCT03756974 (ClinicalTrials.gov) | February 18, 2019 | 20/11/2018 | BX-1 in Spasticity Due to Multiple Sclerosis | A Phase III, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Efficacy and Safety of BX-1 for the Symptomatic Relief of Spasticity in Patients With Multiple Sclerosis (MS) | Spasticity Due to Multiple Sclerosis | Drug: BX-1;Drug: Placebo | Bionorica SE | NULL | Recruiting | 18 Years | 65 Years | All | 384 | Phase 3 | Czechia;Germany;Hungary;Poland;Spain |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 101 | NCT03623243 (ClinicalTrials.gov) | February 14, 2019 | 7/8/2018 | Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients. | Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study | Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis | Drug: Siponimod | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 65 Years | All | 400 | Phase 3 | United States;Puerto Rico |
| 102 | NCT03784547 (ClinicalTrials.gov) | February 1, 2019 | 13/12/2018 | Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAM | Real-world Patient Profile and Treatment Persistence of Ocrelizumab in Multiple Sclerosis: A Retrospective Analysis in Latin America | Multiple Sclerosis | Drug: Ocrelizumab | Hospital Italiano de Buenos Aires | NULL | Recruiting | N/A | N/A | All | 100 | Argentina | |
| 103 | NCT03825601 (ClinicalTrials.gov) | February 1, 2019 | 21/1/2019 | PET With [18F]Flumazenil as an Index of Neurodegeneration in MS | PET With [18F]Flumazenil as an Index of Neurodegeneration in MS: Sensitivity at an Early Disease Stage and Pathophysiological Meaning | Multiple Sclerosis;Relapsing-Remitting Multiple Sclerosis | Diagnostic Test: PET with [11C]Flumazenil | Institut National de la Santé Et de la Recherche Médicale, France | NULL | Not yet recruiting | 18 Years | 55 Years | All | 45 | N/A | NULL |
| 104 | NCT03846219 (ClinicalTrials.gov) | January 28, 2019 | 21/1/2019 | MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS) | Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial Assessing the Effect of IMU-838 on Disease Activity, as Measured by Magnetic Resonance Imaging (MRI), as Well as Safety and Tolerability in Patients With Relapsing-remitting Multiple Sclerosis (RRMS) | Relapsing-Remitting Multiple Sclerosis (RRMS) | Drug: IMU-838 (30 mg/day);Drug: IMU-838 (45 mg/day);Drug: Placebo | Immunic AG | NULL | Active, not recruiting | 18 Years | 55 Years | All | 210 | Phase 2 | Bulgaria;Poland;Romania;Ukraine |
| 105 | EUCTR2017-004702-17-PL (EUCTR) | 25/01/2019 | 17/10/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 106 | NCT03653273 (ClinicalTrials.gov) | January 24, 2019 | 28/8/2018 | Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP) | Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years | Multiple Sclerosis | Other: DMT withdrawal;Drug: DMT continuation | Rennes University Hospital | NULL | Recruiting | 50 Years | N/A | All | 250 | Phase 3 | France |
| 107 | NCT04595045 (ClinicalTrials.gov) | January 24, 2019 | 9/9/2020 | Botulinum Toxin in Patients With Spastic Lower Limb Paresis Associated With Multiple Sclerosis | Effectiveness of Botulinum Toxin Type A Infiltrations in the Gait and Quality of Life in Adults With Spastic Lower Limb Paresis Secondary to Multiple Sclerosis | Multiple Sclerosis | Drug: Botulinum toxin type A infiltrations | Aránzazu Vázquez Doce | NULL | Recruiting | 18 Years | 80 Years | All | 84 | Phase 3 | Spain |
| 108 | EUCTR2017-004886-29-IE (EUCTR) | 11/01/2019 | 09/05/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | |||
| 109 | NCT04106830 (ClinicalTrials.gov) | January 1, 2019 | 25/9/2019 | Clinical and Imaging Patterns of Neuroinflammation Diseases in China (CLUE) | Prospective Cohort Study of Clinical and Imaging Patterns of Neuroinflammation Diseases (CLUE) | NMO Spectrum Disorder;MRI;Multiple Sclerosis | Drug: Intravenous steroid | Beijing Tiantan Hospital | NULL | Recruiting | 16 Years | 80 Years | All | 1000 | China | |
| 110 | NCT03650114 (ClinicalTrials.gov) | December 28, 2018 | 17/8/2018 | Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS | An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Biological: Ofatumumab;Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap);Biological: 13-valent pneumococcal conjugate vaccine (13-PCV);Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV);Biological: Seasonal Quadrivalent influenza vaccine;Biological: Keyhole limpet hemocyanin (KLH) neo-antigen | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 2010 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;India;Israel;Japan;Latvia;Lithuania;Mexico;Netherlands;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 111 | EUCTR2018-001896-19-BG (EUCTR) | 17/12/2018 | 11/10/2018 | Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) | Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) - EMPhASIS | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Phase 2 | Poland;Ukraine;Romania;Bulgaria | ||
| 112 | NCT03847545 (ClinicalTrials.gov) | December 12, 2018 | 19/12/2018 | Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking Technique | Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking | Multiple Sclerosis | Drug: Fampridine | University of Southern Denmark | Odense University Hospital;Sygehus Lillebaelt;University of Miami;Region of Southern Denmark;The Augustinus Foundation, Denmark.;The Lounkaer Foundation;Fonden for scleroseramte paa Fyn;The Danish Multiple Sclerosis Society;The Lily Benthine Lunds Foundation | Recruiting | 18 Years | 100 Years | All | 60 | N/A | Denmark |
| 113 | JPRN-jRCTs051180080 | 12/12/2018 | 27/02/2019 | Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients | Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients - An open treatment trial of NMO with MMF | Neuromyelitis optica | Mycophenolate mofetil treatment for 1 year | Sekiguchi Kenji | NULL | Recruiting | >= 20age old | < 80age old | Both | 10 | Phase 2 | Japan |
| 114 | EUCTR2017-004702-17-ES (EUCTR) | 12/12/2018 | 17/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | |||
| 115 | EUCTR2018-002315-98-DK (EUCTR) | 06/12/2018 | 09/07/2018 | The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury. | The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI | Central neuropathic pain and spasticity MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10077975;Term: Central neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol capsule 5 mg Product Code: N/A INN or Proposed INN: Cannabidiol Other descriptive name: CBD Product Name: Dronabinol capsule 2,5 mg Product Code: N/A INN or Proposed INN: DRONABINOL Other descriptive name: THC Product Name: Cannabidiol / Dronabinol capsule 5 mg+2,5 mg Product Code: N/A INN or Proposed INN: DRONABINOL Other descriptive name: THC INN or Proposed INN: Cannabidiol Other descriptive name: CBD | Aarhus Universitetshospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | Denmark | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 116 | EUCTR2017-004702-17-BG (EUCTR) | 03/12/2018 | 23/10/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 117 | NCT03536559 (ClinicalTrials.gov) | November 23, 2018 | 2/5/2018 | Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis | A Phase 2, Randomized, DB-PC, Parallel Group Study for the Treatment of Visual Pathway Deficits In Chronic Optic Neuropathy to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of CNM-Au8 For Remyelination In Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis;Optic Neuropathy;Optic; Neuritis, With Demyelination | Drug: CNM-Au8;Drug: Placebo | Clene Nanomedicine | Clene Australia Pty Ltd | Recruiting | 18 Years | 55 Years | All | 150 | Phase 2 | United States;Australia;Canada |
| 118 | NCT03621761 (ClinicalTrials.gov) | November 15, 2018 | 3/8/2018 | Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue | A Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple Sclerosis | Multiple Sclerosis | Behavioral: Telephone-based Cognitive Behavioral Therapy;Drug: Modafinil | University of Michigan | University of Washington;Patient-Centered Outcomes Research Institute;National Multiple Sclerosis Society | Recruiting | 18 Years | N/A | All | 330 | Phase 4 | United States |
| 119 | NCT04120675 (ClinicalTrials.gov) | November 9, 2018 | 24/9/2019 | Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis | Randomized, Double Blind, Controlled Prospective Study, to Evaluate the Therapeutic Effects of Early Harvest Olive Oil in Cognitive Functions of Patients With Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis. | Progressive Multiple Sclerosis | Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil | Aristotle University Of Thessaloniki | Greek Alzheimer's Association and Related Disorders;Yanni's Olive Grove | Recruiting | 18 Years | 65 Years | All | 150 | N/A | Greece |
| 120 | EUCTR2017-004702-17-IT (EUCTR) | 07/11/2018 | 04/11/2020 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND | Multiple sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE Product Name: Formistin 10 mg Product Code: [Formistin 10 mg] Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [Tachipirina CPR 500mg] Other descriptive name: paracetamolo 500 mg Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: Solumedrol IM 125mg/2ml Product Code: [Metilprednisolone] Other descriptive name: Metilprednisolone sodio succinato Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: Ofatumumab Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: OFATUMUMAB | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 121 | EUCTR2018-000001-23-ES (EUCTR) | 06/11/2018 | 23/08/2018 | Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosis | A phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS | Symptomatic relief of spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dronabinol Product Code: BX-1 INN or Proposed INN: Dronabinol Other descriptive name: Dronabinol | Bionorica SE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 548 | Phase 3 | Hungary;Spain | ||
| 122 | EUCTR2017-004702-17-LV (EUCTR) | 02/11/2018 | 03/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Germany;Latvia;Italy | ||
| 123 | NCT03593590 (ClinicalTrials.gov) | November 2, 2018 | 11/7/2018 | Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis | A Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDY | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 18 Years | N/A | All | 1250 | Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Dominican Republic;Egypt;Italy;Kuwait;Montenegro;Netherlands;Panama;Paraguay;Poland;Portugal;Qatar;Romania;Russian Federation;Saudi Arabia;Slovakia;Spain;Turkey;United Arab Emirates;United Kingdom;Israel | |
| 124 | EUCTR2017-004702-17-LT (EUCTR) | 31/10/2018 | 17/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 125 | EUCTR2018-000001-23-HU (EUCTR) | 25/10/2018 | 16/08/2018 | Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosis | A phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS | Symptomatic relief of spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Bionorica SE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 548 | Phase 3 | Czech Republic;Hungary;Spain | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 126 | EUCTR2017-004702-17-CZ (EUCTR) | 23/10/2018 | 16/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 127 | EUCTR2018-003231-30-ES (EUCTR) | 19/10/2018 | 17/09/2018 | EFFECTIVENESS OF REPEATED INJECTIONS OF BOTULINUM TOXIN IN THE GAIT AND QUALITY OF LIFE OF ADULT PATIENTS WITH WEAKNESS AND MUSCLE RIGIDITY DUE TO MULTIPLE ESCLEROSIS | EFFECTIVENESS OF THE REPEATED INFILTRATIONS OF BOTULINUM TOXIN A IN THE GAIT AND QUALITY OF LIFE IN ADULTS WITH SPASTIC PARAPARESIA SECONDARY TO MULTIPLE SCLEROSIS - BOTULINUM TOXIN IN PATIENTS WITH SPASTIC PARAPARESIA ASSOCIATED WITH ESCLEROSIS MULTIPLE | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport INN or Proposed INN: BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Aránzazu Vázquez Doce | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 3 | Spain | ||
| 128 | EUCTR2017-004702-17-EE (EUCTR) | 17/09/2018 | 28/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Czech Republic;Estonia;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 129 | NCT03606460 (ClinicalTrials.gov) | September 14, 2018 | 23/7/2018 | A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS) | A Phase IIIb, Open-Label Study To Evaluate The Safety And Tolerability Of Shorter Infusions Of Ocrelizumab In Patients With Primary Progressive And Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab Dose 1;Drug: Ocrelizumab Dose 2 and Dose 3 | Genentech, Inc. | NULL | Completed | 18 Years | 55 Years | All | 141 | Phase 3 | United States |
| 130 | EUCTR2017-004158-40-FR (EUCTR) | 11/09/2018 | 04/07/2018 | NA | A Prospective study evaluating the effect of ocrelizumab on brain innate immune Microglial cells Activation in Multiple Sclerosis using PET-MRI with 18F-DPA714 - INN-MS | Patients with Relapsing MS or primary progressive MS MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 71 | Phase 3 | France | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 131 | NCT03560739 (ClinicalTrials.gov) | September 11, 2018 | 15/5/2018 | A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients | A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients | Multiple Sclerosis | Combination Product: ofatumumab with PRF;Combination Product: ofatumumab with AI | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 284 | Phase 2 | United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain |
| 132 | EUCTR2017-004886-29-NL (EUCTR) | 05/09/2018 | 27/06/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 133 | EUCTR2017-004702-17-AT (EUCTR) | 01/09/2018 | 10/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 134 | EUCTR2017-004886-29-CZ (EUCTR) | 08/08/2018 | 10/05/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | |||
| 135 | NCT03589105 (ClinicalTrials.gov) | August 6, 2018 | 5/7/2018 | A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting | An Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab 300 mg;Drug: Ocrelizumab 600 mg | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | All | 423 | Phase 4 | France |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 136 | NCT03584672 (ClinicalTrials.gov) | August 5, 2018 | 30/6/2018 | The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis. | The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis. | Multiple Sclerosis | Other: Static Balance Test;Other: Berg Balance Scale;Other: Timed Up an Go Test;Other: Four Square Step Test;Other: Functional Reach Test;Other: One-leg Stance Test | Gazi University | NULL | Unknown status | 18 Years | N/A | All | 30 | NULL | |
| 137 | EUCTR2018-001292-21-FR (EUCTR) | 27/07/2018 | 05/06/2018 | Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years | Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years | Secondary Progressive Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | CHU de Rennes | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | France | |||
| 138 | EUCTR2016-004719-10-FI (EUCTR) | 25/07/2018 | 12/06/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 139 | EUCTR2017-004886-29-SE (EUCTR) | 23/07/2018 | 05/06/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1224 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 140 | NCT03562975 (ClinicalTrials.gov) | July 23, 2018 | 23/5/2018 | Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus | A Single-center Prospective Measurement of Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus™ | Multiple Sclerosis;Pathologic Processes;Demyelinating Diseases;Nervous System Diseases;Autoimmune Diseases;Immune System Diseases;Primary Progressive Multiple Sclerosis;Relapsing Remitting Multiple Sclerosis | Drug: Ocrelizumab | University of South Florida | Genentech, Inc. | Active, not recruiting | 18 Years | 70 Years | All | 18 | United States | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 141 | NCT03567057 (ClinicalTrials.gov) | July 18, 2018 | 22/5/2018 | A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment | A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment | Multiple Sclerosis;Walking Impairment | Drug: ADS-5102 | Adamas Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | 70 Years | All | 540 | Phase 3 | United States;Canada |
| 142 | NCT03599245 (ClinicalTrials.gov) | July 12, 2018 | 25/6/2018 | This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS) | A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 1500 | Phase 4 | Czechia;Denmark;Estonia;Finland;France;Ireland;Italy;Netherlands;Norway;Spain;Sweden;United Kingdom |
| 143 | EUCTR2017-001313-93-CZ (EUCTR) | 09/07/2018 | 26/03/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Panama;United Arab Emirates;Morocco;Spain;Costa Rica;Guatemala;Lebanon;Ireland;Russian Federation;Colombia;Italy;Egypt;France;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Denmark;Netherlands;Germany;Algeria;Bosnia and Herzegovina | |||
| 144 | EUCTR2017-004886-29-FR (EUCTR) | 05/07/2018 | 17/05/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | |||
| 145 | EUCTR2018-000721-31-SE (EUCTR) | 04/07/2018 | 24/04/2018 | A clincial study comparing the effectiveness of two doses of the drug Rituximab during long-term treatment of the neurological disease Multiple Sclerosis. | RItuximab Long-Term DOSE Trial in Multiple Sclerosis – RIDOSE-MSA randomized trial of long-term dosage of rituximab in multiple sclerosisThe RIDOSE-MS trial is a multi-centre trial of long-term treatment with rituximab in MS, randomised between two different dosing regimens. Population: Patients with RRMS that has completed the RIFUND-MS trial in either the rituximab or DMF arm. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.Intervention: Treatment with rituximab (Mabthera®) 500 mg every six months. Both the previous rituximab and DMF arms from the RIFUND trial will be treated with rituximab in the RIDOSE trial.Control: After one year of treatment in RIDOSE-MS, patients will be randomised 1:1 to either continue with 500 mg every 6 months or 500 mg every 12 months and continue on this treatment schedule for another 3 years.Outcome: Primary outcome will be the proportion of patients remaining with no evidence of disease activity (NEDA) -3 over the randomised period of 3 years. As secondary endpoints progression of disability, brain atrophy, cognitive function and level of serum Neurofilament-Light will be evaluated. In addition, Patient-related outcome scales measuring fatigue, work ability and treatment satisfaction will be analysed. - RIDOSE-MS | Patients with multiple sclerosis (MS), 20 - 52 years of age, that have completed the RIFUND-MS trial (EudraCT 2015-004116-38) will be offered to continue in this extension trial, RODOSE-MS. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB | Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 146 | EUCTR2017-004886-29-GB (EUCTR) | 03/07/2018 | 02/07/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1224 | Phase 3 | France;Czech Republic;Estonia;Finland;Spain;Ireland;Denmark;Netherlands;United Kingdom;Sweden | ||
| 147 | EUCTR2016-004719-10-PT (EUCTR) | 02/07/2018 | 12/02/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | |||
| 148 | EUCTR2017-001362-25-DK (EUCTR) | 27/06/2018 | 21/03/2018 | Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. | Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS | Relapsing remitting multiple sclerosis. MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Helse Bergen HF, Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | Denmark;Netherlands | |||
| 149 | EUCTR2017-004886-29-DK (EUCTR) | 21/06/2018 | 18/05/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1224 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 150 | EUCTR2017-001313-93-HU (EUCTR) | 21/06/2018 | 25/04/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 151 | NCT03423121 (ClinicalTrials.gov) | June 19, 2018 | 12/1/2018 | A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis | A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS Patients | Progressive Multiple Sclerosis | Drug: Tauroursodeoxycholic Acid;Drug: Placebo oral capsule | Johns Hopkins University | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 1;Phase 2 | United States |
| 152 | EUCTR2017-004886-29-FI (EUCTR) | 19/06/2018 | 15/06/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 153 | EUCTR2017-001313-93-PL (EUCTR) | 08/06/2018 | 15/03/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria | |||
| 154 | EUCTR2017-004886-29-EE (EUCTR) | 31/05/2018 | 18/04/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 155 | NCT03552211 (ClinicalTrials.gov) | May 30, 2018 | 25/4/2018 | Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis | Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: biotin;Other: propensity score | University Hospital, Clermont-Ferrand | OFSEP (Observatoire Français de la Sclérose en Plaques);SFSEP (Société Francophone de la Sclérose en Plaques);MedDay Pharmaceuticals SA | Unknown status | 18 Years | 80 Years | All | 3000 | France | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 156 | NCT03523858 (ClinicalTrials.gov) | May 28, 2018 | 16/4/2018 | A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis | An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis (PMS) | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 900 | Phase 3 | United States;Bosnia and Herzegovina;Brazil;Canada;Colombia;Costa Rica;Czechia;Denmark;Egypt;France;Germany;Guatemala;Hungary;Ireland;Italy;Lebanon;Mexico;Morocco;Netherlands;Panama;Poland;Russian Federation;Saudi Arabia;Spain;United Arab Emirates;Algeria |
| 157 | EUCTR2017-004886-29-ES (EUCTR) | 22/05/2018 | 09/04/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Roche Farma SA (Soc unipersonal) que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | |||
| 158 | NCT03610139 (ClinicalTrials.gov) | May 21, 2018 | 13/7/2018 | Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients | Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients: A Single-Blind Randomized Clinical Trial | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting;Clinically Isolated Syndrome;Clinically Isolated Syndrome, CNS Demyelinating;Vitamin D3 Deficiency | Dietary Supplement: Vitamin D3 | American University of Beirut Medical Center | NULL | Unknown status | 18 Years | N/A | All | 162 | N/A | Lebanon |
| 159 | EUCTR2017-001313-93-ES (EUCTR) | 11/05/2018 | 02/03/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria | ||
| 160 | NCT03498131 (ClinicalTrials.gov) | May 9, 2018 | 6/4/2018 | Melatonin in Patients With Multiple Sclerosis (MS). | Evaluating the Potential Role of Melatonin in Subjects With Relapsing Multiple Sclerosis (MS) | Relapsing Remitting Multiple Sclerosis | Drug: 3 mg Melatonin;Drug: 5 mg Melatonin | Providence Health & Services | NULL | Recruiting | 18 Years | 65 Years | All | 30 | Early Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 161 | EUCTR2017-001313-93-IE (EUCTR) | 03/05/2018 | 06/02/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 (development) INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 (commercial) INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria | ||
| 162 | NCT03585569 (ClinicalTrials.gov) | May 1, 2018 | 16/3/2018 | Treating MS Patients With Lower Extremity Spasticity Using Dysport | A Prospective, Open Label, Single Center Study of Patients With Multiple Sclerosis With Lower Extremity Spasticity Who Are Treated With Dysport | Multiple Sclerosis;Spasticity, Muscle | Biological: Abobotulinumtoxin A | Neurology Center of New England P.C. | Ipsen | Unknown status | N/A | N/A | All | 30 | Phase 3 | United States |
| 163 | EUCTR2017-004100-22-HR (EUCTR) | 27/04/2018 | 16/05/2019 | Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 164 | EUCTR2017-004101-40-HR (EUCTR) | 27/04/2018 | 16/05/2019 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 165 | EUCTR2016-004719-10-GB (EUCTR) | 26/04/2018 | 22/05/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 166 | EUCTR2018-000620-34-SE (EUCTR) | 24/04/2018 | 14/03/2018 | Imatinib treatment for Multiple Sclerosis (MS) Relapses | Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS | Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: IMATINIB MESILATE Trade Name: Solu-Medrol Product Name: Solu-Medrol INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Department of Clinical Neuroscience, Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Sweden | ||
| 167 | EUCTR2017-000426-35-AT (EUCTR) | 17/04/2018 | 12/03/2018 | The efficacy of treatment of patients with multiple sclerosis, a chronic, inflammatory, autoimmune, disease that leads to neurologic deficits and aggravates with flairs, with low doses of rituximab, an antibody directed against the CD20 epitope on B Lymphocytes, specific cells of the immune system contributing to the progression of the disease - a pilot trial | Efficacy of Rituximab at low doses in Multiple Sclerosis – A prospective, randomized, double-blind, active controlled, pilo trial - Low-dose Rituximab in MS | Relapse Remitting Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera or biosimilar rituximab product Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: Mabthera or biosimilar rituximab product Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB | Medical University of Vienna - Department of Neurology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | Austria | ||
| 168 | NCT03501342 (ClinicalTrials.gov) | April 9, 2018 | 10/4/2018 | Effects of Immersive Virtual Reality on Balance, Mobility, and Fatigue in Patients With Multiple Sclerosis | Effects of Immersive Virtual Reality on Balance, Mobility, and Fatigue in Patients With Multiple Sclerosis | Multiple Sclerosis | Other: Virtual reality group;Other: Dynamic Balance Training | Gazi University | NULL | Completed | 18 Years | 65 Years | All | 39 | N/A | Turkey |
| 169 | NCT04550650 (ClinicalTrials.gov) | April 6, 2018 | 10/9/2020 | Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients | Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients | Multiple Sclerosis, Chronic Progressive;Multiple Sclerosis, Primary Progressive | Other: Training groupe;Other: PNF;Other: Spinning grp;Other: Balance | Somogy Megyei Kaposi Mór Teaching Hospital | NULL | Completed | 35 Years | 60 Years | All | 4 | N/A | Hungary |
| 170 | EUCTR2017-001313-93-DK (EUCTR) | 04/04/2018 | 23/02/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United Arab Emirates;Panama;Morocco;Spain;Costa Rica;Guatemala;Lebanon;Ireland;Russian Federation;Colombia;Italy;Egypt;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Netherlands;Germany;Algeria;Bosnia and Herzegovina | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 171 | NCT03319732 (ClinicalTrials.gov) | April 3, 2018 | 13/10/2017 | A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005) | Multiple Sclerosis;Spasticity, Muscle | Drug: Arbaclofen | Osmotica Pharmaceutical US LLC | NULL | Active, not recruiting | 18 Years | 65 Years | All | 323 | Phase 3 | United States |
| 172 | JPRN-UMIN000031135 | 2018/04/01 | 01/04/2018 | Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients | Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients - An open treatment trial of NMO with MMF | Neuromyelitis Optica | Mycophenolate mofetil treatment for 1 year | Kobe University Hospital | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 10 | Not selected | Japan |
| 173 | NCT03436199 (ClinicalTrials.gov) | March 29, 2018 | 12/2/2018 | Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment | A 3-arm, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ADS-5102 Amantadine Extended Release Capsules in Multiple Sclerosis Patients With Walking Impairment | Walking Impairment;Multiple Sclerosis | Drug: ADS-5102, 137 mg;Drug: ADS-5102, 274 mg;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 594 | Phase 3 | United States;Canada |
| 174 | EUCTR2016-004719-10-HR (EUCTR) | 27/03/2018 | 12/04/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | |||
| 175 | EUCTR2017-004101-40-BG (EUCTR) | 23/03/2018 | 09/01/2018 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 176 | EUCTR2017-004101-40-PL (EUCTR) | 21/03/2018 | 12/02/2018 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 177 | NCT03477500 (ClinicalTrials.gov) | March 21, 2018 | 13/2/2018 | RCT Comparing Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab in MS | Randomized Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab for Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Cyclophosphamide and ATG;Drug: Alemtuzumab | Haukeland University Hospital | NULL | Recruiting | 18 Years | 50 Years | All | 100 | Phase 3 | Denmark;Netherlands;Norway;Sweden |
| 178 | EUCTR2017-004100-22-PL (EUCTR) | 21/03/2018 | 09/02/2018 | Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 179 | EUCTR2017-004100-22-BG (EUCTR) | 16/03/2018 | 08/01/2018 | Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 180 | JPRN-JapicCTI-173711 | 15/3/2018 | 14/09/2017 | Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab | A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab | Relapsing Multiple Sclerosis | Intervention name : Ofatumumab INN of the intervention : - Dosage And administration of the intervention : Ofatumumab 20 mg subcutaneous injections every 4 weeks Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo subcutaneous injection matching to ofatumumab every 4 weeks | Novartis Pharma K.K. | NULL | complete | 18 | 55 | BOTH | 30 | Phase 2 | Japan, Russia |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 181 | NCT03249714 (ClinicalTrials.gov) | March 15, 2018 | 11/8/2017 | Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab | A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab | Relapsing Multiple Sclerosis | Drug: Ofatumumab subcutaneous injection;Drug: Placebo subcutaneous injection matching ofatumumab | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 64 | Phase 2 | Japan;Russian Federation |
| 182 | EUCTR2017-001176-31-PT (EUCTR) | 12/03/2018 | 01/03/2018 | A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Norway;Sweden | ||
| 183 | NCT03005119 (ClinicalTrials.gov) | March 1, 2018 | 25/12/2016 | Evaluation of the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in MS Patients With Spasticity-related Symptoms | A Phase II, Double-blind, Randomized, Placebocontrolled, Parallel-group, Single-center Study to Evaluate the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in Multiple Sclerosis (MS) Patients With Spasticity-related Symptoms | Multiple Sclerosis | Drug: PTL201;Drug: Placebo Oral Capsule | PhytoTech Therapeutics, Ltd. | NULL | Not yet recruiting | 18 Years | 65 Years | All | 70 | Phase 2 | Israel |
| 184 | EUCTR2016-004414-10-SE (EUCTR) | 23/02/2018 | 02/01/2018 | Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily. | Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily. | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | MS Centrum, Department of Neurology, Sshlgrenska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | Sweden | ||
| 185 | NCT03551275 (ClinicalTrials.gov) | February 22, 2018 | 13/2/2018 | Dose Escalation Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 in Patients With Relapsing-Remitting Multiple Sclerosis | A Multicenter Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC BIOCAD, Russia) in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Biological: BCD-132 | Biocad | NULL | Unknown status | 18 Years | 60 Years | All | 48 | Phase 1 | Russian Federation |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 186 | NCT03401879 (ClinicalTrials.gov) | February 1, 2018 | 10/1/2018 | Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis | Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Optic Neuritis | Device: Dynamic Vessel Analyzer (DVA);Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT);Device: Optical coherence tomography (OCT);Device: Optical coherence tomography angiography (OCTA) | Medical University of Vienna | NULL | Recruiting | 18 Years | N/A | All | 50 | N/A | Austria |
| 187 | EUCTR2016-004719-10-LV (EUCTR) | 30/01/2018 | 10/11/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | |||
| 188 | NCT03290131 (ClinicalTrials.gov) | January 28, 2018 | 19/9/2017 | A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis | Multiple Sclerosis;Spasticity, Muscle | Drug: Arbaclofen;Drug: Placebo | Osmotica Pharmaceutical US LLC | NULL | Completed | 18 Years | 65 Years | All | 536 | Phase 3 | Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Moldova, Republic of;Poland;Serbia;United States |
| 189 | NCT03399981 (ClinicalTrials.gov) | January 24, 2018 | 9/1/2018 | Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries | An Observational Study Utilising Data From the US Tysabri TOUCH Programme and Select EU MS Registries to Estimate the Risk of Progressive Multifocal Leukoencephalopathy (PML) and Other Serious Opportunistic Infections Among Patients Who Were Exposed to an MS Disease Modifying Treatment Prior to Treatment With Tysabri | Progressive Multifocal Leukoencephalopathy | Biological: Tysabri | Biogen | NULL | Active, not recruiting | N/A | N/A | All | 72600 | United States | |
| 190 | EUCTR2016-004719-10-BG (EUCTR) | 24/01/2018 | 01/11/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 191 | EUCTR2016-004719-10-CZ (EUCTR) | 22/01/2018 | 29/09/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 192 | EUCTR2016-004719-10-HU (EUCTR) | 11/01/2018 | 20/11/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 193 | NCT03135249 (ClinicalTrials.gov) | January 1, 2018 | 12/4/2017 | Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis | Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis (SUPPRESS) | Multiple Sclerosis (MS) | Drug: Alemtuzumab | University of Texas Southwestern Medical Center | Genzyme, a Sanofi Company | Active, not recruiting | 18 Years | 60 Years | All | 40 | Phase 4 | United States |
| 194 | NCT03670459 (ClinicalTrials.gov) | December 31, 2017 | 7/9/2018 | Forty Five Patients With Multiple Sclerosis Recieved Vestibular Rehabilitation and Balance Training | Cawthorne Cooksey Versus Vestibular Habituation Exercises on Trunk Kinetics and Velocity of Gait in Patients With Multiple Sclerosis | Neurologic Disorder | Other: Cawthorne Cooksey exercises;Other: Vestibular habituation exercises;Other: Balance exercises | October 6 University | NULL | Completed | 35 Years | 55 Years | All | 45 | N/A | Egypt |
| 195 | EUCTR2016-004719-10-LT (EUCTR) | 29/12/2017 | 04/12/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 196 | NCT03385356 (ClinicalTrials.gov) | December 19, 2017 | 20/12/2017 | Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis | Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Vitamin D Deficiency | Drug: Vitamin D | University Medical Centre Maribor | Medical Faculty Maribor | Completed | 18 Years | 60 Years | All | 89 | Phase 4 | Slovenia |
| 197 | EUCTR2017-004846-31-SI (EUCTR) | 14/12/2017 | 05/12/2017 | Vitamin D supplementation in patients with multiple sclerosis | Impact of vitamin D supplementation in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 20.1;Level: LLT;Classification code 10064137;Term: Progression of multiple sclerosis;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Oleovit D3 14.400 IU/ml oral drops, solution | University medical centre Maribor | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 95 | Phase 4 | Slovenia | ||
| 198 | EUCTR2017-001176-31-FR (EUCTR) | 07/12/2017 | 16/01/2018 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | |||
| 199 | EUCTR2017-001176-31-CZ (EUCTR) | 07/12/2017 | 03/08/2017 | A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 200 | EUCTR2016-004719-10-PL (EUCTR) | 02/12/2017 | 24/08/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 201 | NCT03315923 (ClinicalTrials.gov) | December 1, 2017 | 17/10/2017 | Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients | Comparison of Expanded Disability Status Scale, Gad-enhanced Brain Lesions, Annualized Relapse Rate, and Side Effects Between Active Secondary Progressive Multiple Sclerosis Patients on Rituximab and Glatiramer Acetate | Secondary Progressive Multiple Sclerosis | Drug: Rituximab;Drug: Glatiramer Acetate | Isfahan University of Medical Sciences | NULL | Completed | 18 Years | 55 Years | All | 84 | Phase 2;Phase 3 | Iran, Islamic Republic of |
| 202 | NCT03353974 (ClinicalTrials.gov) | December 1, 2017 | 16/11/2017 | Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients. | The Role of Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients. A Pilot Randomized Controlled Trial. | Multiple Sclerosis | Device: Video game therapy;Device: Balance platform therapy | University Hospital of Ferrara | NULL | Recruiting | 18 Years | 80 Years | All | 40 | N/A | Italy |
| 203 | EUCTR2016-003100-30-DE (EUCTR) | 29/11/2017 | 07/03/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 204 | EUCTR2016-002937-31-HR (EUCTR) | 29/11/2017 | 13/04/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 205 | NCT03347370 (ClinicalTrials.gov) | November 27, 2017 | 16/11/2017 | A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis | Subcutaneous (SC) Interferon Beta Therapy in Multiple Sclerosis Patients and Characterization of Injection Site Reactions and Flu-Like Symptoms Under Daily Practice Setting | Multiple Sclerosis, Relapsing-Remitting | Drug: SC Peginterferon beta-1a;Drug: SC interferon beta-1a;Drug: SC interferon beta-1b | Biogen | AMS Advanced Medical Services GmbH | Completed | 18 Years | N/A | All | 626 | Germany | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 206 | EUCTR2017-001176-31-GB (EUCTR) | 06/11/2017 | 21/07/2017 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | |||
| 207 | EUCTR2017-002838-23-ES (EUCTR) | 27/10/2017 | 21/07/2017 | Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) | Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) | patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ORY2001 Product Code: ORY2001 INN or Proposed INN: Not yet requested Other descriptive name: PHENYLCYCLOPROPYLAMINE DERIVATIVES AND DUAL LSD1/MAO-B (LYSINE-SPECIFIC DEMETHYLASE 1 AND MONOAMINE OXIDASE-B) INHIBITOR | Oryzon Genomics S. A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Spain | ||
| 208 | EUCTR2016-003100-30-GR (EUCTR) | 27/10/2017 | 21/04/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway;Sweden | ||
| 209 | EUCTR2017-001176-31-DK (EUCTR) | 25/10/2017 | 14/08/2017 | A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 210 | NCT03368664 (ClinicalTrials.gov) | October 24, 2017 | 2/11/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis | Drug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonist | Genzyme, a Sanofi Company | NULL | Active, not recruiting | 10 Years | 17 Years | All | 50 | Phase 3 | Austria;Belgium;Bulgaria;Czechia;France;Germany;Greece;Italy;Netherlands;Poland;Portugal;Russian Federation;Spain;Turkey;United Kingdom;Norway;Switzerland |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 211 | EUCTR2015-005431-41-PL (EUCTR) | 16/10/2017 | 07/04/2016 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Taiwan;Ukraine;Turkey;Russian Federation;Italy;Canada;Poland;Malaysia;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of | |||
| 212 | EUCTR2016-003100-30-NO (EUCTR) | 12/10/2017 | 12/04/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Norway;Germany;Sweden | |||
| 213 | NCT03185065 (ClinicalTrials.gov) | October 4, 2017 | 9/6/2017 | Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis | Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis | Fatigue in Multiple Sclerosis | Drug: Amantadine;Drug: Modafinil;Drug: Methylphenidate;Drug: Placebos | Johns Hopkins University | Patient-Centered Outcomes Research Institute | Completed | 18 Years | N/A | All | 141 | Phase 3 | United States |
| 214 | EUCTR2016-004719-10-SE (EUCTR) | 04/10/2017 | 28/07/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 215 | EUCTR2016-004719-10-ES (EUCTR) | 02/10/2017 | 04/07/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 216 | EUCTR2017-002634-24-SE (EUCTR) | 29/09/2017 | 06/07/2017 | MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis. | MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS | Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Sweden | ||
| 217 | EUCTR2016-003100-30-NL (EUCTR) | 28/09/2017 | 11/05/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Norway;Sweden | ||
| 218 | NCT03326505 (ClinicalTrials.gov) | September 25, 2017 | 9/5/2017 | Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment | The Effect of Stem Cell Therapy and Comprehensive Physical Therapy in Motor and Non-Motor Symptoms in Patients With Multiple Sclerosis: A Comparative Study. | Multiple Sclerosis | Biological: Umbilical cord derived Mesenchymal Stem Cells;Other: Supervised physical therapy | University of Jordan | NULL | Completed | 18 Years | 65 Years | All | 60 | Phase 1;Phase 2 | Jordan |
| 219 | EUCTR2017-001176-31-ES (EUCTR) | 20/09/2017 | 12/07/2017 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden;Portugal;Slovenia | ||
| 220 | NCT03257358 (ClinicalTrials.gov) | September 19, 2017 | 18/8/2017 | A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod | A 12-Month, Prospective, Multicenter, Two-cohort, Nonrandomized, Open-label Study in Adult Patients With Relapsing Multiple Sclerosis (RMS), to Investigate Changes in Immune Phenotype Biomarkers After Treatment With 0.5mg Fingolimod [FLUENT] | Relapsing Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 382 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 221 | EUCTR2016-003622-16-FI (EUCTR) | 19/09/2017 | 27/02/2017 | The effect of teriflunomide on brain microglial cell activation in multiple sclerosis. | Targeting SPMS: Effect of teriflunomide treatment on microglial activation in an MS patient cohort at risk of progression. A [11C]PK11195 Brain PET study. | Multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: AUBAGIO Product Name: Teriflunomide Product Code: L04AA31 | Turku University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Finland | |||
| 222 | NCT03134573 (ClinicalTrials.gov) | September 15, 2017 | 26/4/2017 | Medication Usage and Patient Reported Outcomes Evaluation Via myBETAapp in Patients With Multiple Sclerosis Treated With Betaferon: a Pilot Study | PROmyBETAapp: Ascertaining Medication Usage & Documentation of Patient Reported Outcomes Utilizing the myBETAapp® in Patients With Multiple Sclerosis Treated With Betaferon®: a Pilot Study | Multiple Sclerosis | Drug: Interferon beta-1b (Betaferon, BAY86-5046);Device: Betaconnect auto-injector;Device: myBETAapp | Bayer | NULL | Completed | 18 Years | N/A | All | 96 | Germany | |
| 223 | EUCTR2017-001176-31-FI (EUCTR) | 14/09/2017 | 10/08/2017 | A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 224 | EUCTR2016-002937-31-NO (EUCTR) | 12/09/2017 | 18/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 225 | EUCTR2016-002937-31-DE (EUCTR) | 11/09/2017 | 02/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 226 | NCT03282760 (ClinicalTrials.gov) | September 9, 2017 | 9/8/2017 | Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients | A Phase I Multicenter Study of Allogenic, Intracerebroventricular Human Neural Stem Cells Transplantation for the Experimental Treatment of Secondary Progressive Multiple Sclerosis Patients | Secondary-progressive Multiple Sclerosis | Biological: Human Neural Stem Cells | Casa Sollievo della Sofferenza IRCCS | Associazione Revert ONLUS;Neurocenter of Southern Switzerland;Fondazione Cellule Staminali | Active, not recruiting | 18 Years | 60 Years | All | 24 | Phase 1 | Italy;Switzerland |
| 227 | EUCTR2017-001176-31-AT (EUCTR) | 07/09/2017 | 26/07/2017 | A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 228 | EUCTR2016-002937-31-GB (EUCTR) | 06/09/2017 | 05/09/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 229 | EUCTR2016-003100-30-PT (EUCTR) | 28/08/2017 | 04/05/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 230 | NCT03183869 (ClinicalTrials.gov) | August 24, 2017 | 9/5/2017 | Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients | Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients | Autoimmune Diseases;Relapsing Multiple Sclerosis | Drug: Fecal microbiota | Lawson Health Research Institute | NULL | Terminated | 18 Years | N/A | All | 14 | Phase 2 | Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 231 | EUCTR2017-001253-13-BE (EUCTR) | 23/08/2017 | 11/07/2017 | Does decresaed perfusion of the brain play a role in the reduced function of axons and the clinical disability and fatigue in patients with multiple sclerosis ? | Does cerebral hypoperfusion play a role in reduced axonal metabolism and clinical disability in patients with multiple sclerosis ? - ROCHIMS (Role of Cerebral Hypoperfusion In Multiple Sclerosis) | Patients suffering relapsing- remitting multiple sclerosis will be investigated in this study, with an EDSS score less or equal to 4.0. Patients must be older than 18 years old. There must not be any clinical evidence of an MS relpase within the 3 months prior to inclusion.;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Tracleer | UZ Brussel | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Belgium | ||
| 232 | EUCTR2016-002937-31-NL (EUCTR) | 21/08/2017 | 15/06/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1228 | Phase 3 | Portugal;United States;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Netherlands;Kuwait;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;Sweden | |||
| 233 | NCT02744222 (ClinicalTrials.gov) | August 10, 2017 | 3/4/2016 | Comparative Clinical Trial to Evaluate Efficacy, Safety and Tolerance of BCD-054 and Avonex® for Treatment of Patients With Remitting-relapsing Multiple Sclerosis | An International Multicenter Double-blind Placebo-controlled Randomized Study to Compare the Efficacy, Safety and Tolerability of BCD-054 (JSC BIOCAD, Russia), 180 µg and 240 µg, Versus Avonex® (Biogen Idec Ltd., UK) in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: BCD-054 180 mcg;Biological: Avonex®;Biological: BCD-054 240 mcg;Other: Placebo | Biocad | NULL | Unknown status | 18 Years | 60 Years | All | 399 | Phase 2;Phase 3 | Russian Federation |
| 234 | EUCTR2016-003100-30-AT (EUCTR) | 03/08/2017 | 10/08/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway | ||
| 235 | EUCTR2016-002937-31-BG (EUCTR) | 02/08/2017 | 30/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 236 | NCT03138421 (ClinicalTrials.gov) | August 1, 2017 | 1/5/2017 | Central Pain Study for ABX-1431 | A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of ABX-1431 in Patients With Central Pain | Neuromyelitis Optica Spectrum Disorder;Transverse Myelitis;Multiple Sclerosis;Longitudinally Extensive Transverse Myelitis | Drug: ABX-1431 HCl;Drug: Placebo | Abide Therapeutics | NULL | Completed | 18 Years | N/A | All | 9 | Phase 1 | United Kingdom |
| 237 | EUCTR2016-002937-31-ES (EUCTR) | 31/07/2017 | 29/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | Roche Farma S.A. (Soc.unipersonal)que realiza el ensayo en España y que actúa como representante de F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Slovakia;Spain;Switzerland;Italy;France;Denmark;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 238 | EUCTR2016-002937-31-FR (EUCTR) | 26/07/2017 | 30/10/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Slovakia;Spain;Switzerland;Italy;France;Denmark;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 239 | EUCTR2016-002937-31-PT (EUCTR) | 24/07/2017 | 04/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 240 | NCT03232073 (ClinicalTrials.gov) | July 17, 2017 | 20/7/2017 | Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis | Multicenter, Non-comparative Extension to Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ponesimod | Actelion | NULL | Active, not recruiting | 18 Years | 65 Years | All | 800 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 241 | EUCTR2016-003100-30-BE (EUCTR) | 14/07/2017 | 22/05/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway | ||
| 242 | EUCTR2016-002937-31-BE (EUCTR) | 10/07/2017 | 05/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 243 | NCT02903537 (ClinicalTrials.gov) | July 6, 2017 | 21/7/2016 | Tolerogenic Dendritic Cells as a Therapeutic Strategy for the Treatment of Multiple Sclerosis Patients (TOLERVIT-MS) | Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients (TOLERVIT-MS) | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Chronic Progressive | Drug: Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3);Drug: Interferon-beta | Fundació Institut Germans Trias i Pujol | Clinica Universidad de Navarra, Universidad de Navarra | Unknown status | 18 Years | 60 Years | All | 16 | Phase 1 | Spain |
| 244 | EUCTR2016-002937-31-HU (EUCTR) | 29/06/2017 | 08/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Slovakia;Slovenia;Finland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Poland;Belgium;Brazil;Romania;Croatia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden | ||
| 245 | EUCTR2016-002937-31-PL (EUCTR) | 26/06/2017 | 10/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 246 | EUCTR2016-004935-18-HR (EUCTR) | 26/06/2017 | 12/09/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 247 | EUCTR2016-004935-18-PL (EUCTR) | 26/06/2017 | 07/04/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Spain;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 248 | EUCTR2016-004935-18-BG (EUCTR) | 22/06/2017 | 11/04/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Estonia;Czech Republic;Poland;Spain;Ukraine;Serbia;Hungary;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 249 | EUCTR2016-002937-31-AT (EUCTR) | 19/06/2017 | 20/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 250 | EUCTR2016-002937-31-SE (EUCTR) | 19/06/2017 | 20/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 251 | EUCTR2016-004935-18-DE (EUCTR) | 19/06/2017 | 16/02/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 252 | EUCTR2016-002937-31-SK (EUCTR) | 16/06/2017 | 11/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 253 | EUCTR2016-002937-31-SI (EUCTR) | 16/06/2017 | 13/06/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1228 | Phase 3 | Portugal;United States;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Sweden | |||
| 254 | EUCTR2016-002937-31-DK (EUCTR) | 08/06/2017 | 28/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 255 | NCT03239860 (ClinicalTrials.gov) | June 6, 2017 | 12/7/2017 | Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: GNbAC1 Monoclonal Antibody | GeNeuro SA | Les Laboratoires Servier;Worldwide Clinical Trials;Institut de Recherches Internationales Servier | Terminated | 18 Years | 55 Years | All | 220 | Phase 2 | Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 256 | EUCTR2016-003100-30-GB (EUCTR) | 05/06/2017 | 27/03/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway | ||
| 257 | EUCTR2016-004935-18-CZ (EUCTR) | 01/06/2017 | 20/02/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 258 | NCT02901106 (ClinicalTrials.gov) | May 23, 2017 | 7/9/2016 | Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate | Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate SURV-SEP | Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl fumarate | Fondation Ophtalmologique Adolphe de Rothschild | NULL | Terminated | 18 Years | N/A | All | 11 | Phase 4 | France |
| 259 | EUCTR2016-003587-39-SE (EUCTR) | 22/05/2017 | 23/03/2017 | This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval. | COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS) | Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3700 | Phase 4 | Sweden | ||
| 260 | NCT03269071 (ClinicalTrials.gov) | May 17, 2017 | 30/8/2017 | Neural Stem Cell Transplantation in Multiple Sclerosis Patients | Neural Stem Cell Transplantation in Multiple Sclerosis Patient: a Phase I Study | Progressive Multiple Sclerosis | Drug: human fetal-derived Neural Stem Cells (hNSCs) | IRCCS San Raffaele | Fondazione Italiana Sclerosi Multipla | Enrolling by invitation | 18 Years | 55 Years | All | 4 | Phase 1 | Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 261 | EUCTR2011-005249-12-SI (EUCTR) | 15/05/2017 | 13/03/2017 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Israel;Russian Federation;France;Macedonia, the former Yugoslav Republic of;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;Poland;Bulgaria | |||
| 262 | EUCTR2016-001448-21-PL (EUCTR) | 09/05/2017 | 13/01/2017 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Czech Republic;Slovakia;Spain;Poland;Ukraine;Turkey;Croatia;Russian Federation;Bulgaria;United Kingdom | ||
| 263 | NCT03345940 (ClinicalTrials.gov) | April 30, 2017 | 16/5/2017 | Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis | A Multicentric Randomized PRAGmatic Trial to Compare the Effectiveness of Fingolimod Versus Dimethyl-Fumarate on Patient Overall Disease Experience in Relapsing Remitting Multiple Sclerosis: Novel Data to Inform Decision-makers | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Dimethyl Fumarate | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Patient-Centered Outcomes Research Institute;Universita degli Studi di Genova | Terminated | 18 Years | N/A | All | 55 | Phase 4 | Italy |
| 264 | EUCTR2011-005249-12-PT (EUCTR) | 24/04/2017 | 01/02/2017 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Israel;Russian Federation;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;Poland | ||
| 265 | NCT03073603 (ClinicalTrials.gov) | April 20, 2017 | 18/1/2017 | Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS) | Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS) | Multiple Sclerosis | Drug: Discontinuation of disease modifying therapy;Drug: Standard of Care | University of Colorado, Denver | Patient-Centered Outcomes Research Institute;National Multiple Sclerosis Society;University of Alabama at Birmingham | Active, not recruiting | 55 Years | N/A | All | 260 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 266 | EUCTR2016-004935-18-HU (EUCTR) | 12/04/2017 | 02/02/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Serbia;Estonia;Czech Republic;Hungary;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 267 | EUCTR2016-003100-30-IT (EUCTR) | 11/04/2017 | 14/05/2019 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) - na | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | GENZYME CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 268 | EUCTR2016-001448-21-BG (EUCTR) | 11/04/2017 | 14/02/2017 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria | |||
| 269 | NCT03085810 (ClinicalTrials.gov) | April 4, 2017 | 16/3/2017 | Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS) | An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 1225 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Denmark;France;Germany;Hungary;Italy;Kuwait;Lebanon;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Slovakia;Slovenia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Finland |
| 270 | EUCTR2016-003100-30-ES (EUCTR) | 04/04/2017 | 22/02/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 271 | NCT03110315 (ClinicalTrials.gov) | March 28, 2017 | 28/3/2017 | A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia | A Double-blind, Crossover, Placebo-controlled Study to Compare the Effects of Nighttime Administration of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia | Multiple Sclerosis;Fatigue;Insomnia | Drug: Suvorexant;Drug: Placebo | Theodore R. Brown, MD MPH | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | 75 Years | All | 30 | Phase 4 | United States |
| 272 | EUCTR2016-004935-18-ES (EUCTR) | 24/03/2017 | 10/03/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 273 | EUCTR2011-005249-12-NL (EUCTR) | 15/03/2017 | 08/11/2016 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Greece;Spain;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina | ||
| 274 | NCT03091569 (ClinicalTrials.gov) | March 10, 2017 | 21/3/2017 | Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy | Effects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY) | Relapsing-Remitting Multiple Sclerosis | Other: Vitamin K Cream;Other: Placebo Cream | Biogen | NULL | Completed | 18 Years | N/A | All | 23 | Phase 4 | Italy |
| 275 | NCT02975349 (ClinicalTrials.gov) | March 7, 2017 | 23/11/2016 | A Study of Efficacy and Safety of M2951 in Subjects With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing-remitting Multiple Sclerosis | Drug: M2951;Drug: Placebo;Drug: Tecfidera | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Active, not recruiting | 18 Years | 65 Years | All | 267 | Phase 2 | Bulgaria;Czechia;Poland;Russian Federation;Serbia;Slovakia;Spain;Ukraine;Germany;United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 276 | EUCTR2015-005418-31-FR (EUCTR) | 07/03/2017 | 12/01/2017 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 277 | NCT03164018 (ClinicalTrials.gov) | March 7, 2017 | 29/3/2017 | Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis | Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis | Multiple Sclerosis | Drug: Fampridine | Genesis Pharma CNS & Specialty | NULL | Completed | 18 Years | N/A | All | 111 | Greece | |
| 278 | EUCTR2016-001448-21-SK (EUCTR) | 16/02/2017 | 25/10/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom | |||
| 279 | EUCTR2015-005419-33-HR (EUCTR) | 10/02/2017 | 05/06/2017 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 280 | NCT02949908 (ClinicalTrials.gov) | February 9, 2017 | 17/10/2016 | MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS) | A Phase IV, Prospective, Multicenter, Open Label, Uncontrolled, Non-interventional, Single Arm Study to Measure Treatment Satisfaction of Multiple Sclerosis (MS) Patients on Rebif® After Discontinuing Initial First-line Treatment | Multiple Sclerosis | Drug: Rebif | Merck KGaA, Darmstadt, Germany | Merck B.V., Netherlands | Terminated | 18 Years | 65 Years | All | 2 | Phase 4 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 281 | EUCTR2016-001448-21-CZ (EUCTR) | 06/02/2017 | 01/11/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom | ||
| 282 | NCT03193866 (ClinicalTrials.gov) | February 1, 2017 | 20/4/2017 | COMparison Between All immunoTherapies for Multiple Sclerosis. | COMparison Between All immunoTherapies for Multiple Sclerosis. An Observational Long-term Prospective Cohort Study of Safety, Efficacy and Patient's Satisfaction of MS Disease Modulatory Treatments in Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Rituximab | Karolinska Institutet | Patient-Centered Outcomes Research Institute;Kaiser Foundation Research Institute | Active, not recruiting | 18 Years | N/A | All | 3526 | Sweden | |
| 283 | EUCTR2015-005418-31-CZ (EUCTR) | 31/01/2017 | 14/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;Australia;Denmark;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 284 | EUCTR2015-005419-33-CZ (EUCTR) | 31/01/2017 | 20/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 285 | NCT03177083 (ClinicalTrials.gov) | January 30, 2017 | 26/1/2017 | Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy | Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis (MS) Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™) | Relapsing Remitting Multiple Sclerosis | Drug: peginterferon beta-1a;Drug: interferon beta-1a;Drug: interferon beta-1b | Biogen | NULL | Completed | 18 Years | 65 Years | All | 80 | Phase 4 | Portugal |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 286 | EUCTR2015-005419-33-BG (EUCTR) | 19/01/2017 | 25/11/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany;United States;Portugal | ||
| 287 | EUCTR2016-001448-21-ES (EUCTR) | 05/01/2017 | 26/10/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom | ||
| 288 | NCT03032601 (ClinicalTrials.gov) | January 5, 2017 | 19/1/2017 | Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis | Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis | Multiple Sclerosis | Dietary Supplement: N-acetyl Cysteine | Thomas Jefferson University | NULL | Active, not recruiting | 30 Years | 80 Years | All | 25 | N/A | United States |
| 289 | EUCTR2015-005418-31-NL (EUCTR) | 04/01/2017 | 08/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 290 | NCT03193086 (ClinicalTrials.gov) | January 1, 2017 | 14/6/2017 | The Effect of Alemtuzumab on the Blood-brain-barrier and the Brain's Metabolism in Multiple Sclerosis Patients | The Effect of Alemtuzumab on the Blood-brain-barrier and Cerebral Metabolism in Multiple Sclerosis Patients; a New MRI Method for Treatment Response Evaluation in Multiple Sclerosis | Multiple Sclerosis | Drug: Alemtuzumab | Glostrup University Hospital, Copenhagen | Genzyme, a Sanofi Company | Recruiting | 18 Years | 60 Years | All | 35 | N/A | Denmark |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 291 | NCT02980042 (ClinicalTrials.gov) | January 1, 2017 | 9/11/2016 | Tolerability and Safety of Switching From Rituximab to Ocrelizumab in Patients With Relapsing Forms of Multiple Sclerosis | Evaluating the Tolerability and Safety Profile of Switching From Rituximab to Ocrelizumab: A Real World Evaluation of Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab;Drug: Rituximab | University of Colorado, Denver | NULL | Completed | 18 Years | 65 Years | All | 200 | Phase 3 | United States |
| 292 | NCT02969304 (ClinicalTrials.gov) | December 30, 2016 | 21/10/2016 | Study of Utilization Patterns of Dimethyl Fumarate in Germany | Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany | Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | N/A | N/A | All | 930 | N/A | Germany |
| 293 | NCT03186664 (ClinicalTrials.gov) | December 28, 2016 | 7/6/2017 | The Role of SAtivex® in Robotic-Rehabilitation | The Role of SAtivex® Associated With Robotic-Rehabilitation in Improving the Motor Performances of Multiple Sclerosis Patients (SARR) | Rehabilitation | Device: Lokomat training;Drug: Sativex | IRCCS Centro Neurolesi Bonino-Pulejo | NULL | Completed | 18 Years | 65 Years | All | 40 | N/A | Italy |
| 294 | EUCTR2015-005418-31-HR (EUCTR) | 13/12/2016 | 15/12/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 295 | NCT03561402 (ClinicalTrials.gov) | December 1, 2016 | 7/6/2018 | Biomarkers and Disease Activity in Patients Treated With Teriflunomide (Aubagio) | Association of Possible Biomarkers With Disease Activity in Patients Treated With Teriflunomide (Aubagio) | Multiple Sclerosis, Relapsing-Remitting | Drug: Teriflunomide | McGill University | NULL | Unknown status | 18 Years | 55 Years | All | 75 | Canada | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 296 | NCT02977533 (ClinicalTrials.gov) | December 1, 2016 | 28/11/2016 | A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of GZ402668 in Men and Women With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: GZ402668;Drug: Placebo;Drug: Acyclovir | Sanofi | NULL | Completed | 18 Years | 65 Years | All | 20 | Phase 1 | Germany |
| 297 | EUCTR2015-005418-31-BG (EUCTR) | 01/12/2016 | 12/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 298 | EUCTR2015-005431-41-HR (EUCTR) | 30/11/2016 | 15/12/2016 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 3 | United States;Taiwan;Ukraine;Turkey;Italy;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of | ||
| 299 | EUCTR2015-004616-37-DE (EUCTR) | 24/11/2016 | 05/08/2016 | A Study to Explore the Mechanism of Action of Ocrelizumab and B-cell Biology in Patients with Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis. | An open-label, multicenter, biomarker study to explore the mechanism of action of ocrelizumab and B-cell biology in patients with relapsing multiple sclerosis or primary progressive multiple sclerosis. | - Relapsing multiple sclerosis (RMS)/Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | GENENTECH Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 99 | Phase 3 | United States;Germany;Switzerland;Sweden | ||
| 300 | EUCTR2016-000434-21-PT (EUCTR) | 14/11/2016 | 14/09/2016 | PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™) | PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™) | Relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Plegridy 125 micrograms INN or Proposed INN: Peginterferon beta-1a Other descriptive name: PEGINTERFERON BETA-1A Trade Name: Rebif 22 micrograms INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 44 micrograms INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A Trade Name: Betaferon 250 microgram/ml INN or Proposed INN: Recombinant Interferon Beta-1b Other descriptive name: RECOMBINANT INTERFERON BETA-1B Trade Name: Extavia 250 micrograms/ml INN or Proposed INN: Recombinant Interferon Beta-1b Other descriptive name: RECOMBINANT INTERFERON BETA-1B Trade Name: Plegridy 63 micrograms INN or Proposed INN: Peginterferon beta-1a Other descriptive name: PEGINTERFERON BETA-1A | Biogen Portugal | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 4 | Portugal | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 301 | EUCTR2015-005418-31-PL (EUCTR) | 11/11/2016 | 20/09/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 302 | EUCTR2015-005419-33-LV (EUCTR) | 03/11/2016 | 11/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Portugal;United States;United Arab Emirates;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 303 | NCT02913157 (ClinicalTrials.gov) | November 2016 | 20/9/2016 | Hydroxychloroquine in Primary Progressive Multiple Sclerosis | Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Hydroxychloroquine 200mg BID for Reducing Progression of Disability in Patients With Primary Progressive Multiple Sclerosis (PPMS) | Multiple Sclerosis, Primary Progressive | Drug: Hydroxychloroquine | University of Calgary | NULL | Active, not recruiting | 18 Years | 65 Years | All | 35 | Phase 2 | Canada |
| 304 | EUCTR2015-005418-31-GR (EUCTR) | 21/10/2016 | 05/09/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;France;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 305 | EUCTR2015-005419-33-DE (EUCTR) | 21/10/2016 | 07/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 306 | EUCTR2016-001515-20-IT (EUCTR) | 20/10/2016 | 07/02/2018 | nd | EFFECT OF TERIFLUNOMIDE ON T CELL SUBPOPULATIONS INPERIPHERAL BLOOD FROM RRMS PATIENTS - nd | RELAPSING-REMITTING MULTIPLE SCLEROSIS MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) - 28 COMPRESSE Product Name: teriflunomide Product Code: nd | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Italy | ||
| 307 | EUCTR2015-005418-31-BE (EUCTR) | 17/10/2016 | 07/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 308 | EUCTR2015-005419-33-FR (EUCTR) | 14/10/2016 | 12/01/2017 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Portugal;United Arab Emirates;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 309 | EUCTR2015-005418-31-GB (EUCTR) | 11/10/2016 | 11/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 310 | EUCTR2015-005419-33-GB (EUCTR) | 11/10/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 311 | EUCTR2015-005597-38-CZ (EUCTR) | 07/10/2016 | 17/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 312 | EUCTR2015-005419-33-PT (EUCTR) | 06/10/2016 | 28/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1313 | Phase 3 | United States;United Arab Emirates;Portugal;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Germany | ||
| 313 | EUCTR2015-005419-33-LT (EUCTR) | 03/10/2016 | 23/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Bulgaria;United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Germany | ||
| 314 | NCT02804594 (ClinicalTrials.gov) | October 1, 2016 | 3/6/2016 | A Study of Oxidative Pathways in MS Fatigue | A Phase 2 Randomized, Placebo- Controlled, Parallel Group, Double Blinded Single Center Study on Effect of N-acetyl Cysteine Compared to Placebo on Fatigue in Patients With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis;Fatigue | Drug: N-acetyl cysteine;Drug: Placebo | University of California, San Francisco | NULL | Completed | 18 Years | 75 Years | All | 15 | Phase 2 | United States |
| 315 | NCT01649050 (ClinicalTrials.gov) | October 2016 | 6/7/2012 | Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis | A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Assess the Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis | Muscle Spasticity Due to Multiple Sclerosis | Drug: BGG492;Drug: Placebo | Novartis Pharmaceuticals | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 2 | Germany;Russian Federation |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 316 | NCT02807285 (ClinicalTrials.gov) | October 2016 | 16/6/2016 | Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis | An Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Genentech, Inc. | NULL | No longer available | 18 Years | 55 Years | All | N/A | United States | |
| 317 | EUCTR2016-000345-31-NL (EUCTR) | 30/09/2016 | 11/04/2016 | Reduce the number of natalizumab infusions in patients with multiple sclerosis | Towards personalized dosing of natalizumab in multiple sclerosis - Personalised Dosing of Natalizumab in Multiple Sclerosis (The PDNMS trial) | multiple sclerosis MedDRA version: 18.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: tysabri Product Name: natalizumab INN or Proposed INN: NATALIZUMAB | VU medical center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Netherlands | ||
| 318 | EUCTR2016-003073-18-GB (EUCTR) | 29/09/2016 | 16/09/2016 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Celgene International II Sàrl | NULL | Not Recruiting | Female: no Male: yes | 6 | Phase 1 | United Kingdom | |||
| 319 | EUCTR2015-005419-33-BE (EUCTR) | 26/09/2016 | 11/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United Arab Emirates;United States;Portugal;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 320 | NCT03101735 (ClinicalTrials.gov) | September 23, 2016 | 3/3/2017 | Study to Assess Resource Utilization and Quality of Life of Patients With RRMS Treated With Tecfidera in Greece | A Real Life, Non-interventional, Multicentre Study to Assess Resource Utilization and Quality of Life of Patients With Relapsing Forms of Multiple Sclerosis Treated With Dimethyl Fumarate in Greece - the FIDELITY Study | RRMS | Drug: Dimethyl Fumarate (DMF) | Genesis Pharma CNS & Specialty | NULL | Active, not recruiting | 18 Years | 65 Years | All | 455 | Greece | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 321 | EUCTR2015-005418-31-DK (EUCTR) | 23/09/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 322 | EUCTR2015-005419-33-HU (EUCTR) | 21/09/2016 | 08/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 323 | EUCTR2015-005418-31-HU (EUCTR) | 21/09/2016 | 08/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 324 | EUCTR2015-005419-33-FI (EUCTR) | 20/09/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 325 | JPRN-UMIN000024312 | 2016/09/20 | 25/05/2017 | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. | Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis | Treatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeks | Tsukuba International Clinical Pharmacology Clinic | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 12 | Not selected | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 326 | NCT02792218 (ClinicalTrials.gov) | September 20, 2016 | 2/6/2016 | Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injections | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 930 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Thailand;Turkey;United Kingdom |
| 327 | EUCTR2015-005418-31-SK (EUCTR) | 19/09/2016 | 29/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 328 | EUCTR2015-005419-33-SK (EUCTR) | 19/09/2016 | 03/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 329 | EUCTR2015-005418-31-DE (EUCTR) | 13/09/2016 | 08/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 330 | EUCTR2015-005597-38-FI (EUCTR) | 12/09/2016 | 21/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 331 | EUCTR2015-005418-31-EE (EUCTR) | 12/09/2016 | 10/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 332 | EUCTR2016-000283-41-DK (EUCTR) | 12/09/2016 | 29/06/2016 | Treatment with dimethyl fumarate in patients with primary progressive multiple sclerosis | Dimethyl fumarate treatment of primary progressive multiple sclerosis - FUMAPMS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Finn Sellebjerg | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | Denmark | |||
| 333 | NCT02861014 (ClinicalTrials.gov) | September 9, 2016 | 5/8/2016 | A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) | An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment | Multiple Sclerosis, Relapsing-Remitting | Biological: Ocrelizumab | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 681 | Phase 3 | Australia;Belgium;Czechia;Denmark;Estonia;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Hong Kong |
| 334 | EUCTR2015-005418-31-SE (EUCTR) | 06/09/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 335 | EUCTR2015-005418-31-ES (EUCTR) | 03/09/2016 | 05/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 336 | EUCTR2015-005419-33-ES (EUCTR) | 03/09/2016 | 05/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United Arab Emirates;Portugal;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 337 | NCT02792231 (ClinicalTrials.gov) | August 26, 2016 | 2/6/2016 | Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. | A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis. | Relapsing Multiple Scelrosis | Drug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injections | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 957 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Finland;France;Germany;Hungary;India;Italy;Latvia;Lithuania;Mexico;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;United Kingdom |
| 338 | EUCTR2015-004059-29-CZ (EUCTR) | 18/08/2016 | 09/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 339 | EUCTR2015-005419-33-AT (EUCTR) | 16/08/2016 | 15/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 340 | EUCTR2015-004059-29-IT (EUCTR) | 09/08/2016 | 27/02/2018 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | GENEURO SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 341 | NCT03436927 (ClinicalTrials.gov) | July 15, 2016 | 11/12/2017 | Comparison of Two Different Virtual Reality Methods in Patients With Multiple Sclerosis | Comparison of the Effects of Two Different Virtual Reality Treatment Methods in Patients With Multiple Sclerosis: A Randomized Controlled Trial | Multiple Sclerosis | Other: Nintendo Wii Fit Balance exercises;Other: Balance Trainer Balance Exercises | Biruni University | Istanbul University | Completed | 25 Years | 60 Years | All | 51 | N/A | NULL |
| 342 | EUCTR2015-005597-38-BE (EUCTR) | 14/07/2016 | 16/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 343 | EUCTR2015-005597-38-NL (EUCTR) | 11/07/2016 | 01/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 344 | EUCTR2015-004059-29-DE (EUCTR) | 04/07/2016 | 16/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 345 | EUCTR2015-004059-29-BG (EUCTR) | 30/06/2016 | 08/04/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 346 | NCT02921035 (ClinicalTrials.gov) | June 30, 2016 | 29/9/2016 | Non-interventional Study to Assess Adherence to Treatment for Patients With Relapsing Multiple Sclerosis | A Multicenter, Prospective, Non-interventional Study to Assess Adherence to Treatment for patIeNts With Relapsing Multiple Sclerosis (RMS) Who Are Prescribed Subcutaneous (sc) Interferon Beta-1a | Relapsing Multiple Sclerosis | Drug: Rebif (Interferon beta-1a) | Merck KGaA, Darmstadt, Germany | Merck Serono Middle East FZ LLC | Completed | 18 Years | 60 Years | All | 594 | Algeria;Argentina;Bahrain;Bulgaria;Egypt;Hungary;Iran, Islamic Republic of;Korea, Republic of;Kuwait;Lebanon;Morocco;Poland;Saudi Arabia;Germany;Tunisia;United Arab Emirates | |
| 347 | EUCTR2015-005597-38-DE (EUCTR) | 29/06/2016 | 07/04/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 348 | EUCTR2014-004650-34-IT (EUCTR) | 27/06/2016 | 05/11/2020 | New strategies for diagnostic, therapeutic and clinical care in neurological diseases | Neuromodulation strategies to enhance the effects of gait rehabilitation in multiple sclerosis patients with cerebellar ataxia - New strategies in neurological diseases | Multiple sclerosis with cerebellar ataxia MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: FAMPYRA - 10 MG - COMPRESSA A RILASCIO PROLUNGATO - USO ORALE - FLACONE (HDPE) 56 COMPRESSE (4 FLACONI DA 14) INN or Proposed INN: FAMPRIDINA Other descriptive name: 4-aminopyridine | IRCCS FONDAZIONE ISTITUTO NEUROLOGICO NAZIONALE C. MONDINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 4 | Italy | ||
| 349 | NCT02797015 (ClinicalTrials.gov) | June 23, 2016 | 26/5/2016 | Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS | A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: RPC1063 | Celgene | NULL | Completed | 18 Years | 55 Years | All | 22 | Phase 1 | United States |
| 350 | EUCTR2016-000464-42-DE (EUCTR) | 13/06/2016 | 11/04/2016 | The Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab | A Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab - LemCourse | Relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 351 | NCT03150966 (ClinicalTrials.gov) | June 8, 2016 | 6/5/2017 | The Immunomodulatory Effects of Oral Nanocurcumin in Multiple Sclerosis Patients | The Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Multiple Sclerosis Patients | Multiple Sclerosis | Drug: Nanocurcumin;Drug: Placebo | Tabriz University of Medical Sciences | NULL | Completed | 18 Years | 65 Years | All | 41 | Phase 2 | Iran, Islamic Republic of |
| 352 | EUCTR2015-005597-38-DK (EUCTR) | 02/06/2016 | 06/04/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 353 | NCT02870023 (ClinicalTrials.gov) | June 2016 | 9/8/2016 | How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis? | How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis? | Multiple Sclerosis | Other: Balance training;Other: Strength training | University of Aarhus | VIA University College;TrygFonden, Denmark;Fondazione Don Carlo Gnocchi Onlus | Completed | 18 Years | N/A | All | 71 | N/A | Denmark |
| 354 | EUCTR2015-005597-38-SE (EUCTR) | 25/05/2016 | 15/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 355 | EUCTR2015-005597-38-EE (EUCTR) | 25/05/2016 | 06/04/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 356 | EUCTR2015-005597-38-FR (EUCTR) | 23/05/2016 | 15/02/2018 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 357 | EUCTR2015-005597-38-GB (EUCTR) | 19/05/2016 | 09/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 358 | EUCTR2015-004059-29-EE (EUCTR) | 16/05/2016 | 22/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Poland;Croatia;Bulgaria;Germany;Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary | ||
| 359 | NCT04633967 (ClinicalTrials.gov) | May 15, 2016 | 26/10/2020 | Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting. | Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting. | Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple Sclerosis | Drug: Alemtuzumab Injection | Maritime Neurology | NULL | Active, not recruiting | 18 Years | 65 Years | All | 30 | Canada | |
| 360 | EUCTR2015-004059-29-PL (EUCTR) | 15/05/2016 | 21/03/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 361 | EUCTR2015-005597-38-IE (EUCTR) | 13/05/2016 | 10/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 362 | NCT02720107 (ClinicalTrials.gov) | May 12, 2016 | 21/3/2016 | Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01) | Long-term Follow up of Patients With Relapsing-remitting Multiple Sclerosis Enrolled in the Multicenter, Single-arm, Open-label Biobank Study (CFTY720DDE01), to Investigate Changes in Biomarkers After 48 Months of Treatment With 0.5 mg Fingolimod (FTY720) | Relapsing-remitting Multiple Sclerosis | Drug: fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 133 | Phase 4 | Germany |
| 363 | EUCTR2015-004059-29-HU (EUCTR) | 04/05/2016 | 08/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Czech Republic;Poland;Croatia;Bulgaria;Germany | ||
| 364 | NCT03566251 (ClinicalTrials.gov) | May 1, 2016 | 11/6/2018 | Core Stability, Trunk Position Sense, Balance and Functional Mobility in Patients With Multiple Sclerosis | The Investigation of the Relationship Between Core Stability and Trunk Position Sense With Balance and Functional Mobility in Patients With Multiple Sclerosis | Physical Therapy | Other: Balance;Other: Functional mobility;Other: Core stability;Other: Trunk position sense | Ankara Yildirim Beyazit University | NULL | Completed | 18 Years | 65 Years | All | 74 | N/A | Turkey |
| 365 | EUCTR2015-004059-29-HR (EUCTR) | 29/04/2016 | 06/07/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Serbia;Estonia;Spain;Ukraine;Croatia;Bulgaria;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 366 | NCT02688985 (ClinicalTrials.gov) | April 29, 2016 | 18/2/2016 | Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS) | An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis | Relapsing Multiple Sclerorsis;Multiple Sclerosis, Primary Progressive | Drug: Ocrelizumab;Procedure: Lumbar Puncture;Drug: Methyloprednisolone;Drug: Antihistamine | Genentech, Inc. | NULL | Active, not recruiting | 18 Years | 55 Years | All | 127 | Phase 3 | United States;Canada;Germany;Sweden |
| 367 | EUCTR2015-005597-38-ES (EUCTR) | 26/04/2016 | 18/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | Roche Farma S.A. que representa en España a F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 368 | EUCTR2015-004059-29-ES (EUCTR) | 20/04/2016 | 17/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 369 | NCT02782858 (ClinicalTrials.gov) | April 2016 | 23/5/2016 | Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS | An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: GNbAC1;Drug: Placebo | GeNeuro SA | Les Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical Trials | Completed | 18 Years | 55 Years | All | 270 | Phase 2 | Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 370 | NCT02769689 (ClinicalTrials.gov) | April 2016 | 17/3/2016 | Methylprednisolone During the Switch Between Natalizumab and Fingolimod | Once a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY) | Multiple Sclerosis | Drug: Methylprednisolone;Drug: Placebo;Drug: natalizumab (NTZ);Drug: fingolimob (FTY) | University Hospital, Clermont-Ferrand | NULL | Recruiting | 18 Years | 65 Years | Both | 56 | Phase 4 | France |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 371 | NCT02738775 (ClinicalTrials.gov) | March 18, 2016 | 10/4/2016 | Phase 2 Study of Ublituximab in Patients With Relapsing Forms of Multiple Sclerosis | A Placebo-Controlled Multi-Center Phase 2 Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis. | Multiple Sclerosis | Biological: Ublituximab;Drug: Placebo | TG Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | All | 48 | Phase 2 | United States |
| 372 | NCT02636829 (ClinicalTrials.gov) | March 2016 | 17/11/2015 | Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis | Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis | Multiple Sclerosis;Rheumatoid Arthritis | Other: QALCIMUM questionnaire;Other: Determination of calcium intake by a dietician interview | Centre Hospitalier Universitaire de Nimes | NULL | Completed | 18 Years | 69 Years | Both | 100 | N/A | France |
| 373 | NCT02575365 (ClinicalTrials.gov) | February 16, 2016 | 12/10/2015 | Effect of Fingolimod on Neurodegeneration | Effect of Fingolimod on Neurodegeneration, Brain Atrophy and Cognitive Impairment in Relapsing Remitting Multiple Sclerosis Patients | Cognition;Brain Volume Loss | Drug: 0,5 mg Fingolimod | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 4 | Phase 4 | Turkey |
| 374 | EUCTR2015-000922-12-DE (EUCTR) | 12/02/2016 | 02/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 375 | NCT02637856 (ClinicalTrials.gov) | February 11, 2016 | 18/12/2015 | A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) | An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment | Multiple Sclerosis, Relapsing-Remitting | Drug: Ocrelizumab | Genentech, Inc. | NULL | Completed | 18 Years | 55 Years | All | 608 | Phase 3 | United States;Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 376 | NCT02652091 (ClinicalTrials.gov) | February 5, 2016 | 5/1/2016 | Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction | Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b (Betaseron, BAY86-5046);Device: BETACONNECT device | Bayer | NULL | Completed | 18 Years | N/A | All | 146 | United States | |
| 377 | NCT02587065 (ClinicalTrials.gov) | February 3, 2016 | 23/10/2015 | Plegridy Satisfaction Study in Participants | Multicenter Interventional Phase IV Study for the Assessment of the Effects on Patient's Satisfaction of Plegridy (Pre-filled Pen) in Subjects With Relapsing-remitting Multiple Sclerosis Unsatisfied With Other Injectable Subcutaneous Interferons (PLATINUM) | Relapsing-Remitting Multiple Sclerosis (RRMS) | Drug: peginterferon beta-1a | Biogen | NULL | Completed | 18 Years | 65 Years | All | 193 | Phase 4 | Italy |
| 378 | EUCTR2015-002820-20-NL (EUCTR) | 03/02/2016 | 21/01/2016 | Are alpha blockers effective in the treatment of bladder elimination problems in female patients with Multiple Sclerosis? | Are alpha blockers effective in the treatment of bladder elimination problems in female patients with Multiple Sclerosis? - Alpha blockers and Multiple Sclerosis (MS) | Bladder dysfunction in Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10069632;Term: Bladder dysfunction;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Silodyx | Erasmus MC Dept. Urology | NULL | Not Recruiting | Female: yes Male: no | 30 | Phase 3 | Netherlands | ||
| 379 | NCT02823951 (ClinicalTrials.gov) | February 2016 | 3/3/2016 | Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif® | Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT) | Relapsing-remitting Multiple Sclerosis | Drug: Rebif;Drug: Tecfidera | IMS HEALTH GmbH & Co. OHG | EMD Serono | Completed | 18 Years | 55 Years | All | 479 | United States;Canada | |
| 380 | EUCTR2015-000922-12-FR (EUCTR) | 28/01/2016 | 26/02/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 381 | EUCTR2015-000922-12-ES (EUCTR) | 12/01/2016 | 13/01/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 820 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 382 | JPRN-UMIN000022201 | 2016/01/10 | 04/05/2016 | The efficacy and safety of tocilizumab in patients with neuromyelitis optica | The efficacy and safety of tocilizumab in patients with neuromyelitis optica - The efficacy and safety of tocilizumab in patients with neuromyelitis optica | neuromyelitis optica | Tocilizumab it to be infused every 4weeks at 8mg/kg of body weight for 2 years. | Department of Neurology, Shimane University Hospital | NULL | Complete: follow-up complete | 20years-old | 74years-old | Male and Female | 3 | Not selected | Japan |
| 383 | EUCTR2015-000922-12-PL (EUCTR) | 05/01/2016 | 03/12/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 384 | EUCTR2015-000922-12-BE (EUCTR) | 04/01/2016 | 01/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 385 | ChiCTR-OPB-16007730 | 2016-01-01 | 2016-01-09 | Mycophenolate Mofetil Treatment of Neuromyelitis Optica in Chinese Patients (MONICA) | Mycophenolate Mofetil Treatment of Neuromyelitis Optica in Chinese Patients (MONICA) | Neuromyelitis optica | Case series:Mycophenolate Mofetil; | The third affiliated hospital,Sun Yat-sen university | NULL | Recruiting | 18 | 65 | Both | Case series:100; | China | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 386 | NCT02809079 (ClinicalTrials.gov) | January 2016 | 12/6/2016 | Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients | Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients | Neuromyelitis Optica Spectrum Disorders;Mycophenolate Mofetil;Efficacy and Safety | Drug: Mycophenolate mofetil;Drug: Prednisone | Third Affiliated Hospital, Sun Yat-Sen University | Zhongshan Ophthalmic Centre, Sun Yat-sen University;Nangfang Hospital, Southern Medical University | Enrolling by invitation | 18 Years | 65 Years | Both | 100 | Phase 4 | NULL |
| 387 | NCT02644044 (ClinicalTrials.gov) | January 2016 | 23/3/2015 | Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study | Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study | To Evaluate the Effect of Therapy With IT MTX on the Disease Course of Patients With Progressive MS | Drug: Intrathecal methotrexate | Tel-Aviv Sourasky Medical Center | NULL | Not yet recruiting | 18 Years | 75 Years | Both | 30 | Phase 0 | NULL |
| 388 | NCT02677077 (ClinicalTrials.gov) | December 31, 2015 | 3/12/2015 | Clinical Disease Activity With Long Term Natalizumab Treatment | MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab | Relapsing-Remitting Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Completed | 18 Years | 65 Years | All | 277 | Belgium;Czechia;Czech Republic | |
| 389 | EUCTR2015-000922-12-IE (EUCTR) | 22/12/2015 | 09/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | |||
| 390 | EUCTR2015-004116-38-SE (EUCTR) | 18/12/2015 | 20/10/2015 | A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis. | RItuximab versus FUmarate in Newly Diagnosed Multiple Sclerosis – RIFUND-MSA randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple SclerosisObjective: To compare the efficacy of rituximab on the ability to prevent relapses in early RRMS and CIS compared with dimethyl fumarate (DMF), which is an approved first-line medication for RRMS today, using a phase 3 design.Population: Patients with newly diagnosed RRMS or CIS with no more than 10 years disease duration (since diagnosis), 18 – 50 years of age and previously not treated with immunomodulating drugs OR treated with first-line injectables. Patients should display protocol-defined clinical or radiological disease activity during the preceding year before screening for inclusion.Intervention: Treatment with rituximab (Mabthera®) with an initial dose of 1000 mg intravenously (iv) followed by 500 mg iv every six months.Control: Treatment with DMF (Tecfidera®) 240 mg twice daily. The two treatments are randomised in a 1:1 proportion.Outcome: Primary outcome is the relative risk of experiencing a relapse during the two–year period for either compound. As secondary endpoints worsening on neurological disability, magnetic-resonance imaging-defined disease activity and effect on cerebrospinal fluid biomarkers will be analysed. In addition, health-economic evaluations of using rituximab as first-line treatment for RRMS will be performed. | Patients with multiple sclerosis (MS) or patients presenting with symptoms highly suspicious of MS while not completely fulfilling diagnostic criteria, 18 - 50 years of age and no more than 10 years of disease duration (from diagnosis). Patients treated with immunomodulatory drugs or treated with first-line injectable therapies (eg interferons or glatiramer acetate) may be included.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Department of Clinical Sciences, Danderyd Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 391 | NCT02587195 (ClinicalTrials.gov) | December 18, 2015 | 22/9/2015 | A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period | A National, Multi-center Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period | Multiple Sclerosis | Drug: Teriflunomide | Centre Hospitalier Universitaire de Nice | NULL | Unknown status | 18 Years | 55 Years | All | 5 | Phase 3 | France |
| 392 | EUCTR2015-000922-12-FI (EUCTR) | 15/12/2015 | 07/12/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 393 | EUCTR2015-000922-12-HR (EUCTR) | 11/12/2015 | 04/02/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 394 | EUCTR2015-002201-11-IT (EUCTR) | 10/12/2015 | 28/09/2016 | Study for the satisfaction assessement of the treatment with Plegridy in patient with Multiple Sclerosis | Multicenter interventional Phase IV study for the assessment of the effects on patient’s satisfaction of Plegridy (pre-filled pen) in subjects with relapsing-remitting multiple sclerosis unsatisfied with other injectable subcutaneous Interferons. PLATINUM STUDY - PLATINUM | Subjects with relapsing-remitting multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: PLEGRIDY - 125 MCG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - PENNA PRERIEMPITA - 0,5 ML - 6 PENNE PRERIEMPITE Product Name: Plegridy Product Code: L03AB13 | BIOGEN IDEC ITALIA S.R.L. | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 4 | Italy | ||
| 395 | EUCTR2013-001151-12-HR (EUCTR) | 08/12/2015 | 01/02/2016 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United States;Saudi Arabia;Taiwan;Hong Kong;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Romania;Croatia;Germany;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 396 | EUCTR2013-001150-10-HR (EUCTR) | 07/12/2015 | 01/02/2016 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | neuromyelitis optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000167619;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | ||
| 397 | NCT02583594 (ClinicalTrials.gov) | December 6, 2015 | 16/10/2015 | A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis | A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: Acyclovir;Drug: Methylprednisolone;Drug: alemtuzumab GZ402673;Drug: Paracetamol;Drug: Loratadine;Drug: Ceterizine;Drug: Dexchlorpheniramine | Genzyme, a Sanofi Company | NULL | Active, not recruiting | 18 Years | N/A | All | 24 | Phase 1 | Spain |
| 398 | EUCTR2011-005677-23-HR (EUCTR) | 25/11/2015 | 01/02/2016 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 399 | EUCTR2015-000922-12-AT (EUCTR) | 19/11/2015 | 01/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 400 | EUCTR2012-003735-32-GR (EUCTR) | 19/11/2015 | 06/08/2015 | Study to compare the efficacy and/or safety of masitinib to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. | A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment | Relapsing-remitting multiple sclerosis (RR MS) MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinb mesylate Other descriptive name: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Bulgaria;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 401 | EUCTR2011-005249-12-LT (EUCTR) | 06/11/2015 | 02/10/2015 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | ||
| 402 | EUCTR2015-000922-12-IT (EUCTR) | 05/11/2015 | 28/02/2018 | A clinical study to assess medication satisfaction in patients with RelapsingRemitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/mlThree Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Studyto Assess Medication Satisfaction in Patients with Relapsing RemittingMultiple Sclerosis (RRMS) Treated with Subcutaneous Injections ofCopaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Comparedto 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE 30 SIRINGHE INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: GLATIRAMER ACETATO Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: GLATIRAMER ACETATO | TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 403 | NCT02686684 (ClinicalTrials.gov) | November 2015 | 11/2/2016 | Tecfidera Diffusion Tensor Imaging | An Open-label, Observational, Single-blinded, Longitudinal Study to Evaluate the Effect of Dimethyl Fumarate on Gray and White Matter Pathology in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis, Dimethyl Fumarate, Diffusion Tensor Imaging Magnetic Resonance Imaging | Drug: Dimethyl fumarate | University at Buffalo | NULL | Completed | 18 Years | N/A | Both | 115 | N/A | NULL |
| 404 | NCT02545868 (ClinicalTrials.gov) | October 27, 2015 | 8/9/2015 | A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis | A Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: 23-PPV;Biological: 13-PCV Booster;Biological: Influenza Vaccine;Biological: KLH;Drug: OCR;Biological: TT Vaccine | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 102 | Phase 3 | United States;Canada |
| 405 | EUCTR2010-021219-17-BG (EUCTR) | 27/10/2015 | 13/11/2013 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;South Africa;Tunisia;Germany;Bosnia and Herzegovina | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 406 | NCT02576717 (ClinicalTrials.gov) | October 16, 2015 | 28/9/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients | Multiple Sclerosis | Drug: RPC1063 | Celgene | NULL | Active, not recruiting | 18 Years | 55 Years | All | 2495 | Phase 3 | United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Croatia;Estonia;Georgia;Germany;Greece;Hungary;Italy;Latvia;Lithuania;Moldova, Republic of;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Ukraine;United Kingdom |
| 407 | EUCTR2014-005624-98-IT (EUCTR) | 14/10/2015 | 23/02/2018 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety ofBG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | BIOGEN IDEC RESEARCH LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Peru;South Africa;Netherlands;Kuwait;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany | ||
| 408 | EUCTR2012-003056-36-FR (EUCTR) | 06/10/2015 | 19/06/2013 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 409 | NCT02529839 (ClinicalTrials.gov) | October 2015 | 10/6/2015 | Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation (BMT) in Patients With Multiple Sclerosis (MS) | Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation in Patients With Multiple Sclerosis | Multiple Sclerosis | Procedure: Autologous bone marrow transplantation;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Alemtuzumab | Hadassah Medical Organization | NULL | Not yet recruiting | 18 Years | 65 Years | Both | 20 | N/A | NULL |
| 410 | EUCTR2014-003498-41-AT (EUCTR) | 22/09/2015 | 06/08/2015 | Effects of dalfampridine on mobility in the context of daily life | Effects of dalfampridine on mobility in the context of daily life - Fampridine Study in Activities of Daily Living | Motor behaviour and cognition in multiple sclerosis patients;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra INN or Proposed INN: FAMPRIDINE | Medical University of Vienna | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Austria | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 411 | EUCTR2014-002320-27-NL (EUCTR) | 15/09/2015 | 08/01/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 412 | EUCTR2014-005624-98-HU (EUCTR) | 09/09/2015 | 16/07/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 172 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Peru;South Africa;Netherlands;Kuwait;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany | |||
| 413 | NCT02486640 (ClinicalTrials.gov) | September 8, 2015 | 15/6/2015 | Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon | BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence | Multiple Sclerosis | Drug: Interferon beta-1b (Betaferon, BAY86-5046);Device: Betaconnect Autoinjector | Bayer | NULL | Completed | 18 Years | N/A | All | 162 | Germany | |
| 414 | NCT03002038 (ClinicalTrials.gov) | September 2015 | 21/12/2016 | Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients | Comparison of Annual Relapse Rate, Expanded Disability Status Scale, and Side Effects Between Azathioprine and Rituximab in Patients With Neuromyelitis Optica Spectrum Disorders | Neuromyelitis Optica Spectrum Disorder | Drug: Azathioprine;Drug: Rituximab | Isfahan University of Medical Sciences | NULL | Completed | 18 Years | 50 Years | All | 86 | Phase 2;Phase 3 | Iran, Islamic Republic of |
| 415 | EUCTR2014-005493-11-FR (EUCTR) | 31/08/2015 | 15/03/2018 | Study the action of a single dose of intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets, assuming that a definitive action upon CSF biological targets would be strongly predictive of a delayed clinical action in patients with Progressive Multiple Sclerosis. | Intrathecal Rituximab in Progressive Multiple Sclerosis - EFFRITE | Patients included in our study suffer from a progressive form of Multiple sclerosis and will be treated by intravenous and intrathecal rituximab, with intravenous methylprednisolone.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Centre Hospitalier de Pau | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | France | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 416 | EUCTR2014-004562-22-DE (EUCTR) | 10/08/2015 | 27/05/2015 | Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera® Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Germany;Italy | ||
| 417 | NCT02499900 (ClinicalTrials.gov) | August 10, 2015 | 1/7/2015 | Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone® | CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily | Multiple Sclerosis | Drug: Copaxone® | Teva Pharmaceutical Industries, Ltd. | NULL | Completed | 18 Years | N/A | All | 861 | Phase 4 | United States;Argentina;Austria;Belgium;Croatia;Finland;France;Germany;Ireland;Italy;Mexico;Poland;Puerto Rico;Russian Federation;Spain;Turkey |
| 418 | EUCTR2014-000395-26-DE (EUCTR) | 07/08/2015 | 09/04/2014 | Description ofchanges in that part of the nervous sstem that is processing visual information over an extended perion of time in patients with relapsing remitting multiple sclerosis who take Tecfidera | A 3-year open-label, exploratory, single arm study to describe long term changes in the visual system of patients with relapsing remitting multiple sclerosis (RRMS) on oral dimethyl fumarate - VISION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera INN or Proposed INN: Dimethyl fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 4 | Germany | ||
| 419 | EUCTR2014-004562-22-CZ (EUCTR) | 28/07/2015 | 21/04/2015 | Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose isEffective in Reducing the Incidence of Gastrointestinal Adverse Events inPatients with Multiple Sclerosis | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3b | France;United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Germany;Italy | ||
| 420 | EUCTR2014-002320-27-HR (EUCTR) | 27/07/2015 | 01/10/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 421 | EUCTR2014-002320-27-GB (EUCTR) | 22/07/2015 | 17/06/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 422 | EUCTR2014-004483-38-DE (EUCTR) | 16/07/2015 | 28/04/2015 | TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trial | TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trial | Patients with defined diagnosis of relapsing-remitting multiple sclerosis and at least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tarenflurbil Product Code: TMP001 INN or Proposed INN: Tarenflurbil Other descriptive name: FLURBIPROFEN | Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | Germany | ||
| 423 | EUCTR2014-004562-22-HU (EUCTR) | 13/07/2015 | 30/04/2015 | Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3b | France;United States;Czech Republic;Hungary;Canada;Belgium;Spain;Australia;Germany;Italy | ||
| 424 | EUCTR2014-003021-18-DE (EUCTR) | 09/07/2015 | 30/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | United States;Serbia;Slovakia;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 425 | EUCTR2014-002320-27-HU (EUCTR) | 03/07/2015 | 11/05/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1346 | Phase 3 | Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 426 | EUCTR2014-001643-20-SE (EUCTR) | 03/07/2015 | 19/01/2015 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | Germany;Italy;Switzerland;Sweden;United States;Czech Republic;Mexico;Canada;Poland;Russian Federation | ||
| 427 | NCT02472938 (ClinicalTrials.gov) | July 2015 | 11/5/2015 | Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis | Phase IV, Interventional, multicenteR, Double-blind, Randomized, Placebo-controlled Study tO Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With relapsingremitTing Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: dimethyl fumarate;Other: Placebo | Biogen | GB Pharma Services & Consulting S.r.l. Unipersonale | Withdrawn | 18 Years | 50 Years | Both | 0 | Phase 4 | NULL |
| 428 | NCT02665221 (ClinicalTrials.gov) | July 2015 | 22/1/2016 | Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY | Single Center, Randomized, Open Label Study in Relapsing MS Patients on PLEGRIDY to Assess Topical Application of Preparation H (Phenylephrine) on Mitigation of Erythema Severity and Size. | Multiple Sclerosis | Other: No Treatment Arm;Drug: Topical Preparation H arm | New York University School of Medicine | NULL | Terminated | 18 Years | 70 Years | All | 32 | Phase 4 | United States |
| 429 | NCT02696590 (ClinicalTrials.gov) | July 2015 | 18/2/2016 | High Dose Oral Versus Intramuscular Vitamin D3 Supplementation In Multiple Sclerosis Patients | Isfahan University of Medical Sciences | Relapsing Remitting Multiple Sclerosis | Dietary Supplement: Vitamin D3 | Isfahan University of Medical Sciences | NULL | Completed | 23 Years | 59 Years | Both | 200 | N/A | Iran, Islamic Republic of |
| 430 | EUCTR2014-003021-18-DK (EUCTR) | 25/06/2015 | 09/04/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 431 | EUCTR2015-000303-21-IT (EUCTR) | 24/06/2015 | 01/04/2015 | Experimental clinical trial regarding relapsing-remitTing Multiple Sclerosis newly diagnosed patients, not yet treated for the evaluation of the onset, the efficacy and speed of action of the treatment with BG00012 | A Phase IV, interventional, multicenteR, double-blind, randomized, placebo-controlled study tO explore the onset of efficacy on Magnetic resonance disease activity of BG00012 (dimethyl fumarate) in Patients with relapsing-remitTing Multiple Sclerosis (PROMPT) - PROMPT | Relapsing-remitting Multiple Sclerosis patients MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera® Product Name: Tecfidera® Product Code: BG00012 INN or Proposed INN: Dimethyl fumarate | Biogen Idec Italia S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Italy | |||
| 432 | EUCTR2014-004562-22-IT (EUCTR) | 24/06/2015 | 06/05/2015 | Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose isEffective in Reducing the Incidence of Gastrointestinal Adverse Events inPatients with Multiple Sclerosis | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Germany;Italy | ||
| 433 | EUCTR2014-003021-18-CZ (EUCTR) | 22/06/2015 | 13/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 434 | EUCTR2011-005249-12-PL (EUCTR) | 11/06/2015 | 07/07/2014 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis with Relapsing Forms of Multiple Sclerosis Followed byan Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | United States;Estonia;Greece;Spain;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;Canada;Poland;Belgium;Australia;China | |||
| 435 | EUCTR2014-004562-22-BE (EUCTR) | 10/06/2015 | 09/04/2015 | Study to evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 17.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Germany;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 436 | EUCTR2014-002320-27-LT (EUCTR) | 09/06/2015 | 17/04/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 437 | EUCTR2014-003021-18-IT (EUCTR) | 05/06/2015 | 18/02/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 438 | EUCTR2013-002660-17-DK (EUCTR) | 02/06/2015 | 16/04/2015 | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS | multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolmod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 281 | Phase 2 | Portugal;France;Canada;Finland;Poland;Spain;Denmark;Germany;Italy;United Kingdom;Switzerland | ||
| 439 | EUCTR2014-003021-18-FI (EUCTR) | 02/06/2015 | 28/05/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 440 | EUCTR2014-003021-18-BE (EUCTR) | 02/06/2015 | 24/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 441 | NCT02239393 (ClinicalTrials.gov) | June 2015 | 10/9/2014 | Safety and Efficacy of Intravenous Autologous Mesenchymal Stem Cells for MS: a Phase 2 Proof of Concept Study | MEsenchymal Stem Cell Therapy for CAnadian MS Patients | Multiple Sclerosis | Biological: Mesenchymal Stem Cells | Ottawa Hospital Research Institute | NULL | Completed | 18 Years | 50 Years | All | 31 | Phase 2 | Canada |
| 442 | EUCTR2013-001055-12-IT (EUCTR) | 28/05/2015 | 03/06/2013 | Study to evaluate the efficacy of cetirizine in the treatment of Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß. | Flu-like syndrome Inhibition Giving anti-histaminic Therapy. Randomized cross-over, single-center, randomized, placebo-controlled, double-blind study to evaluate the efficacy of cetirizine on Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß. - FLU-LIGHT | Patients with relapsing remitting multiple sclerosis (RRMS) treated with interferoneß, suffering from flu-like syndrome (FLS). MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Cetirizina Mylan Generics Product Name: Cetirizina Mylan Generics INN or Proposed INN: Cetirizina Other descriptive name: CETIRIZINE HYDROCHLORIDE | Biogen Idec Italia S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 443 | NCT02315872 (ClinicalTrials.gov) | May 22, 2015 | 9/12/2014 | ACTH for Fatigue in Multiple Sclerosis Patients | The Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients With Relapsing Multiple Sclerosis. | Multiple Sclerosis, Relapsing-Remitting | Drug: ACTH;Drug: Placebo | Providence Health & Services | Mallinckrodt | Completed | 18 Years | 65 Years | All | 8 | Phase 3 | United States |
| 444 | EUCTR2014-001579-30-NL (EUCTR) | 21/05/2015 | 26/11/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Germany;Netherlands;Italy;United Kingdom | ||
| 445 | EUCTR2014-003021-18-SK (EUCTR) | 19/05/2015 | 10/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | United States;Serbia;Slovakia;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 446 | EUCTR2013-001025-53-ES (EUCTR) | 18/05/2015 | 03/03/2015 | A Study that evaluates Fatigue in Multiple Sclerosis Patients taking Tecfidera® (Dimethyl Fumarate) | A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsule (TECNERGY) - TECNERGY | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera (BG00012) Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera (BG00012) Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Spain;Denmark;Norway;Netherlands;United Kingdom | |||
| 447 | EUCTR2014-003021-18-PL (EUCTR) | 17/05/2015 | 30/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 448 | EUCTR2014-003481-25-DE (EUCTR) | 13/05/2015 | 17/02/2015 | Investigation of the effect of Dimethyl fumarate on T cells in patients with relapsing remitting Multiple Sclerosis | A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on Immune-Modulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis - DIMAT-MS | relapsing remitting multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera® 120mg magensaftresistente Hartkapseln INN or Proposed INN: Dimethyl fumarate Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera® 240mg magensaftresistente Hartkapseln INN or Proposed INN: Dimethyl fumarate Other descriptive name: DIMETHYL FUMARATE | Universitätsklinikum Münster | NULL | Not Recruiting | Female: yes Male: yes | 67 | Phase 4 | Germany | ||
| 449 | EUCTR2014-003265-19-PL (EUCTR) | 12/05/2015 | 26/02/2015 | Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839 | A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839 | Relapsing-remitting multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden | ||
| 450 | EUCTR2013-003752-21-ES (EUCTR) | 07/05/2015 | 11/03/2015 | A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 17.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SA237 INN or Proposed INN: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody | Chugai Pharmaceutical Co. Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 451 | NCT02461069 (ClinicalTrials.gov) | May 6, 2015 | 27/5/2015 | Investigation of the Effect of Dimethyl Fumarate on T Cells in Patients With Relapsing Remitting Multiple Sclerosis | A 24-week, Multicenter, Exploratory, Two Arm Study to Assess the Effect of Dimethyl Fumarate on Immune-Modulatory Action on T Cells in Patients With Relapsing Remitting Multiple Sclerosis (DIMAT-MS) | Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl fumarate | University Hospital Muenster | Biogen | Completed | 18 Years | 60 Years | All | 67 | Phase 4 | Germany |
| 452 | EUCTR2014-003021-18-AT (EUCTR) | 04/05/2015 | 30/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 453 | EUCTR2013-003752-21-HU (EUCTR) | 04/05/2015 | 25/02/2015 | A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 18.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SA237 INN or Proposed INN: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody | Chugai Pharmaceutical Co. Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;United States;Taiwan;Hungary;Poland;Spain;Germany;Japan;Italy;United Kingdom | ||
| 454 | EUCTR2014-003021-18-NL (EUCTR) | 01/05/2015 | 12/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | United States;Serbia;Slovakia;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 455 | NCT02419638 (ClinicalTrials.gov) | May 2015 | 14/4/2015 | Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS | Multiple Sclerosis | Drug: Rebif (IFN ß-1a subcutaneous three times per week);Drug: Tecifdera (dimethyl fumarate) | Brigham and Women's Hospital | EMD Serono | Withdrawn | 18 Years | 65 Years | Both | 0 | N/A | United States | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 456 | NCT02323269 (ClinicalTrials.gov) | May 2015 | 18/12/2014 | Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve) | A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve) | Multiple Sclerosis, Relapsing-Remitting;Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Terminated | 18 Years | N/A | Both | 24 | N/A | Canada |
| 457 | NCT02471222 (ClinicalTrials.gov) | May 2015 | 11/6/2015 | Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment | Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment | Walking Impairment;Multiple Sclerosis | Drug: ADS-5102;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 60 | Phase 2 | United States |
| 458 | EUCTR2013-003884-71-DK (EUCTR) | 30/04/2015 | 24/02/2015 | Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409 | A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ | Relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1248 | Phase 3;Phase 4 | United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Germany;Netherlands;Sweden | ||
| 459 | EUCTR2014-005548-17-FR (EUCTR) | 28/04/2015 | 03/06/2015 | TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR:A CONTROLED OPEN-LABEL STUDY | TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR:A CONTROLED OPEN-LABEL STUDY | PENDULAR NYSTAGMUS IN PATIENTS WITH MULTIPLE SCLEROSIS OR OCULOPALATAL TREMOR MedDRA version: 18.0;Level: PT;Classification code 10029864;Term: Nystagmus;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: NEURONTIN Product Name: Gabapentine Product Code: N03AX12 Other descriptive name: GABAPENTIN Trade Name: EBIXA Product Name: MEMANTINE Product Code: N06DX01 INN or Proposed INN: MEMANTINE | HOSPICES CIVILS DE LYON | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | France | |||
| 460 | EUCTR2013-001150-10-CZ (EUCTR) | 22/04/2015 | 19/09/2014 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | Neuromyelitis optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Martinique;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 461 | EUCTR2013-001151-12-CZ (EUCTR) | 22/04/2015 | 19/09/2014 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Thailand;Spain;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden;Taiwan;Hong Kong;Martinique | |||
| 462 | EUCTR2014-002320-27-ES (EUCTR) | 21/04/2015 | 09/02/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. - Sunbeam | Relapsing Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 463 | EUCTR2012-003735-32-SK (EUCTR) | 01/04/2015 | 09/04/2015 | Study to compare the efficacy and/or safety of masitinib at 3 mg/kg/day with switch to 4.5 then to 6 mg/kg/day to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. | A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment | Prospective, multicentre, randomised, open-label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 mg/kg/day with switch to 4.5 then 6 mg/kg/day as single agent first line treatment.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Slovakia;Greece;Spain;Colombia;Switzerland;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;Germany | |||
| 464 | NCT02939079 (ClinicalTrials.gov) | April 2015 | 14/10/2016 | Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients | Evaluating the Effect of Fingolimod With Fish Oil Compared to Fingolimod With Placebo on Tumor Necrosis Factor-a , Interleukin1b , Interleukin6, and Interferon-gamma in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod;Dietary Supplement: Fish Oil;Drug: Placebo (for Fish Oil) | Isfahan University of Medical Sciences | Shiraz University of Medical Sciences | Completed | 18 Years | 45 Years | All | 50 | Phase 2;Phase 3 | NULL |
| 465 | NCT02398461 (ClinicalTrials.gov) | April 2015 | 13/3/2015 | An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse | A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse | Multiple Sclerosis, Acute Relapsing | Drug: rHIgM22;Drug: Placebo | Acorda Therapeutics | PRA Health Sciences | Completed | 18 Years | 70 Years | All | 27 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 466 | NCT02428231 (ClinicalTrials.gov) | April 2015 | 23/4/2015 | Tecfidera Slow-Titration Study | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Terminated | 18 Years | 65 Years | All | 62 | Phase 3 | United States;Belgium;Czech Republic;Italy;Australia;Canada;France;Germany;Hungary;Spain |
| 467 | NCT02373098 (ClinicalTrials.gov) | March 31, 2015 | 4/2/2015 | Fingolimod Effect on Cytokine and Chemokine Levels | Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod 0.5 mg | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 126 | Phase 4 | Turkey |
| 468 | EUCTR2013-001151-12-DK (EUCTR) | 25/03/2015 | 11/02/2015 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hong Kong;Taiwan;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Singapore;Croatia;Romania;Germany;Japan;Sweden | ||
| 469 | EUCTR2014-003021-18-SE (EUCTR) | 25/03/2015 | 13/02/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 470 | EUCTR2014-001579-30-DE (EUCTR) | 20/03/2015 | 11/11/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 471 | NCT02386566 (ClinicalTrials.gov) | March 20, 2015 | 6/2/2015 | Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab | A Prospective, Multicenter, Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Patients Treated With Natalizumab | Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Completed | 18 Years | 65 Years | All | 48 | Switzerland | |
| 472 | EUCTR2014-002320-27-BG (EUCTR) | 19/03/2015 | 21/01/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 473 | EUCTR2014-003145-99-GB (EUCTR) | 19/03/2015 | 19/01/2015 | A trial to determine bexarotene's safety and tolerability and it's ability to promote brain repair in patients with multiple sclerosis. | A randomised placebo-controlled study of the safety and tolerability of a retinoid-X receptor agonist's ability to promote remyelination in people with relapsing-remitting multiple sclerosis already on interferon-beta therapy: a phase 2a trial - CCMR One | Relapsing-remitting multiple sclerosis already on interferon-beta therapy MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targretin Product Name: Bexarotene INN or Proposed INN: Bexarotene | Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United Kingdom | ||
| 474 | NCT02410278 (ClinicalTrials.gov) | March 12, 2015 | 2/4/2015 | Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera | A Multicenter, Double- Blind, Placebo- Controlled Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera® (Dimethyl Fumarate) Delayed Release Capsules | Multiple Sclerosis | Drug: dimethyl fumarate;Drug: montelukast;Drug: Placebo | Biogen | NULL | Completed | 18 Years | N/A | All | 102 | Phase 4 | United States |
| 475 | EUCTR2013-001150-10-DK (EUCTR) | 06/03/2015 | 11/02/2015 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | neuromyelitis optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Martinique;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 476 | EUCTR2013-001025-53-DK (EUCTR) | 05/03/2015 | 24/03/2014 | A Study that evaluates Fatigue in Multiple Sclerosis Patients taking Tecfidera® (Dimethyl Fumarate) | A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsule - TECNERGY | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera (BG00012) Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera (BG00012) Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 4 | Finland;Spain;Denmark;Norway;Netherlands;United Kingdom | ||
| 477 | EUCTR2014-002320-27-PL (EUCTR) | 01/03/2015 | 27/01/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 478 | NCT02343159 (ClinicalTrials.gov) | February 28, 2015 | 9/1/2015 | Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients. | A Multicenter, Open-label Phase IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS®) Can Improve Adherence to Tecfidera® (Delayed-release Dimethyl Fumarate) Treatment in Multiple Sclerosis Patients. | Multiple Sclerosis | Drug: dimethyl fumarate;Device: Medication Event Monitoring System (MEMS);Behavioral: Adherence counseling | Biogen | NULL | Terminated | 18 Years | 65 Years | All | 84 | Phase 4 | United States |
| 479 | EUCTR2009-010788-18-PL (EUCTR) | 17/02/2015 | 18/08/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Alemtuzumab INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 480 | EUCTR2014-002320-27-SE (EUCTR) | 12/02/2015 | 08/12/2014 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 481 | EUCTR2015-000182-31-NL (EUCTR) | 11/02/2015 | 26/01/2015 | Study to evaluate the effects of fampridine in patients with multiple sclerosis and eye movement abnormality | A randomized, double-blind, placebo-controlled, cross-over study to assess the effects of fampridine on eye movements and nerve conduction in patients with multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO) | Multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra 10 mg prolonged-release tablets INN or Proposed INN: FAMPRIDINE | CHDR | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 482 | EUCTR2014-001643-20-DE (EUCTR) | 10/02/2015 | 18/08/2014 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden | ||
| 483 | EUCTR2013-003884-71-BE (EUCTR) | 05/02/2015 | 04/08/2014 | Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409 | A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ | Relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 799 | Phase 3B;Phase 4 | Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 484 | EUCTR2013-003884-71-NL (EUCTR) | 02/02/2015 | 11/08/2014 | Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409 | A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ | Relapsing-remitting multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 799 | Phase 3;Phase 4 | United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 485 | NCT02587806 (ClinicalTrials.gov) | February 2015 | 26/10/2015 | A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | An Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | Multiple Sclerosis, Relapsing-Remitting | Biological: Autologous Bone Marrow-Derived Mononuclear Stem Cells;Other: Liberation therapy | Novo Cellular Medicine Institute LLP | NULL | Recruiting | 18 Years | 60 Years | Both | 69 | Phase 1;Phase 2 | India;Trinidad and Tobago |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 486 | NCT02418351 (ClinicalTrials.gov) | February 2015 | 8/4/2015 | A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | An Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | Multiple Sclerosis, Relapsing-Remitting | Biological: Autologous Bone Marrow-Derived Mononuclear Stem Cells;Other: Liberation therapy | Genesis Limited | NULL | Terminated | 18 Years | 60 Years | Both | 69 | Phase 1;Phase 2 | India;Trinidad and Tobago |
| 487 | NCT02587715 (ClinicalTrials.gov) | February 2015 | 26/10/2015 | A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | An Open-label, Non-randomized, Phase I/II Study of Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and Liberation Therapy (When Associated With Chronic Cerebrovascular Venous Insufficiency) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Biological: Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells;Other: Liberation therapy | Novo Cellular Medicine Institute LLP | NULL | Recruiting | 18 Years | 60 Years | Both | 69 | Phase 1;Phase 2 | Trinidad and Tobago |
| 488 | NCT02308137 (ClinicalTrials.gov) | February 2015 | 2/12/2014 | Domperidone in Secondary Progressive Multiple Sclerosis (SPMS) | Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Domperidone 10mg QID for Reducing Progression of Disability in Patients With Secondary Progressive Multiple Sclerosis (SPMS) | Multiple Sclerosis, Secondary Progressive | Drug: Domperidone | University of Calgary | Alberta Innovates Health Solutions | Completed | 18 Years | 60 Years | All | 64 | Phase 2 | Canada |
| 489 | NCT02306811 (ClinicalTrials.gov) | February 2015 | 1/12/2014 | Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839 | A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839 | Relapsing-remitting Multiple Sclerosis | Drug: Vatelizumab | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 62 | Phase 2 | United States;Canada;Poland;Russian Federation |
| 490 | NCT02638038 (ClinicalTrials.gov) | February 2015 | 16/12/2015 | This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for = 3 Years | A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing Remitting | Drug: INT131 | InteKrin Therapeutics, Inc. | NULL | Completed | 18 Years | 50 Years | All | 228 | Phase 2 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 491 | NCT02418325 (ClinicalTrials.gov) | February 2015 | 8/4/2015 | A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | An Open-label, Non-randomized, Phase I/II Study of Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and Liberation Therapy (When Associated With Chronic Cerebrovascular Venous Insufficiency) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Biological: Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells;Other: Liberation therapy | Genesis Limited | NULL | Terminated | 18 Years | 60 Years | Both | 69 | Phase 1;Phase 2 | Trinidad and Tobago |
| 492 | NCT03092544 (ClinicalTrials.gov) | February 2015 | 23/6/2016 | Investigating Indirect Mechanism of Neuroprotection of Tecfidera® (Dimethyl Fumarate) in RRMS and Progressive Patients | Investigating Indirect Mechanism of Neuroprotection of Tecfidera® (Dimethyl Fumarate) in RRMS and Progressive Patients | Multiple Sclerosis | Drug: dimethyl fumarate | Multiple Sclerosis Center of Northeastern New York | Icahn School of Medicine at Mount Sinai;Biogen | Unknown status | 18 Years | 65 Years | All | 57 | Phase 4 | United States |
| 493 | EUCTR2014-002320-27-LV (EUCTR) | 23/01/2015 | 30/10/2014 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 494 | EUCTR2014-001643-20-PL (EUCTR) | 23/01/2015 | 31/10/2014 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden | ||
| 495 | EUCTR2014-004412-11-GB (EUCTR) | 16/01/2015 | 19/11/2014 | The purpose of this study is to examine the safety and efficacy of VSN16R and the performance in treating spasticity (tightness, stiffness or pull of muscles) in patients with Multiple Sclerosis (MS). | A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 19.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: VSN16R 100mg Product Code: VSN16R INN or Proposed INN: VSN16R Other descriptive name: (R) 3-(5-Dimethylcarbamoyl-pent-1-enyl)-N-(2-hydroxy-1- methylethyl) benzamide | Canbex Therapeutics Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 496 | NCT02284568 (ClinicalTrials.gov) | January 12, 2015 | 31/10/2014 | A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo | A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS) | Primary Progressive Multiple Sclerosis | Drug: Placebo;Drug: Laquinimod | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 25 Years | 55 Years | All | 374 | Phase 2 | United States;Canada;Germany;Italy;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom |
| 497 | NCT02255656 (ClinicalTrials.gov) | January 7, 2015 | 30/9/2014 | Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409 | A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409) | Relapsing Remitting Multiple Sclerosis | Drug: alemtuzumab GZ402673 | Genzyme, a Sanofi Company | NULL | Active, not recruiting | 18 Years | N/A | All | 812 | Phase 4 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Spain;Sweden;Ukraine;United Kingdom;Czech Republic |
| 498 | EUCTR2012-005086-12-PL (EUCTR) | 07/01/2015 | 16/09/2014 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Serbia;Hungary;Poland;Ukraine;Austria;Russian Federation;Bulgaria;Germany | ||
| 499 | EUCTR2013-002660-17-PT (EUCTR) | 02/01/2015 | 14/11/2014 | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS | multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolmod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 281 | Phase 2 | France;Portugal;Canada;Finland;Poland;Spain;Denmark;Germany;Italy;United Kingdom;Switzerland | ||
| 500 | NCT02003144 (ClinicalTrials.gov) | January 2015 | 18/11/2013 | An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients | A Phase III, Open-label, Extension Trial of ECU-NMO-301 to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO) | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Biological: eculizumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 119 | Phase 3 | United States;Argentina;Australia;Canada;Colombia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;France;Singapore |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 501 | NCT02427776 (ClinicalTrials.gov) | January 2015 | 2/4/2015 | A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis | A Clinical Trial to Document Safety and Radiological Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis Treated With Autologous CD4+ T Cells, Stimulated and Expanded ex Vivo by a Myelin Oligodendrocyte Glycoprotein Peptide Modified by the Introduction of a Thioreductase Motif Into the Flanking Residues of the Cell Epitope - A First-in-human Trial (SCLEROLYM TRIAL) | Multiple Sclerosis, Relapsing-Remitting | Biological: Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope | Imcyse SA | NULL | Terminated | 18 Years | 50 Years | All | 2 | Phase 1;Phase 2 | Belgium |
| 502 | NCT02606929 (ClinicalTrials.gov) | January 2015 | 12/11/2015 | Use of Well Known Drugs for New Destination - MS Improvement (MSNT) | Expanded Access Retrospective Study About the Use of Well Known Drugs in Combination to Obtain a New Drug to Improve Quality of Life/Health in Patient With Diagnosed Multiple Sclerosis Not Responding With Commonly Used Treatments | Multiple Sclerosis;Autoimmune Diseases;Disseminated or Multiple Sclerosis Nos;Multiple Sclerosis, Acute Relapsing;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Chronic Progressive | Drug: Tetracycline - Statin - Antimycotic | Università Popolare Homo & Natura | NULL | Temporarily not available | 18 Years | 65 Years | Both | Phase 0 | Italy | |
| 503 | NCT02364986 (ClinicalTrials.gov) | January 2015 | 10/12/2014 | Immune- and miRNA-response to Recombinant Interferon Beta in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis | Immune- and miRNA-response to Recombinant Interferon Beta in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Rebif®;Drug: Avonex | PD Dr. Marcus Müller | BfARM, Bonn;DZNE, Bonn | Recruiting | 18 Years | 65 Years | Both | 50 | Phase 1 | Germany |
| 504 | NCT02254304 (ClinicalTrials.gov) | December 31, 2014 | 29/9/2014 | Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™ | Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania Using Electronic Device RebiSmart™ | Relapsing Multiple Sclerosis;Clinically Isolated Syndrome | Drug: Rebif | Merck KGaA, Darmstadt, Germany | Merck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany | Completed | 18 Years | 65 Years | All | 106 | Phase 4 | Germany |
| 505 | EUCTR2013-003884-71-HR (EUCTR) | 30/12/2014 | 30/03/2015 | Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409 | A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ | Relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 799 | Phase 3;Phase 4 | Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden;United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 506 | EUCTR2013-003884-71-DE (EUCTR) | 23/12/2014 | 27/10/2014 | Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409 | A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ | Relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1248 | Phase 3;Phase 4 | United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 507 | EUCTR2013-003884-71-IT (EUCTR) | 22/12/2014 | 28/10/2014 | Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409 | A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ | Relapsing-remitting multiple sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 799 | Phase 3;Phase 4 | Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 508 | EUCTR2014-001579-30-ES (EUCTR) | 22/12/2014 | 23/10/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 509 | EUCTR2014-000709-10-DE (EUCTR) | 19/12/2014 | 13/10/2014 | Investigation on how alemtuzumab acts in patients with relapsing remitting multiple sclerosis. | Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential - ALAIN01 | relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: LEMTRADA 12 mg Konzentrat zur Herstellung einer Infusionslösung INN or Proposed INN: Alemtuzumab Other descriptive name: ALEMTUZUMAB | Universitätsklinikum Münster | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 4 | Germany | ||
| 510 | EUCTR2014-002547-17-NL (EUCTR) | 18/12/2014 | 01/12/2014 | Imaging of inflammation in the cortex of the brain in progressive MS patients | Grey matter microglial imaging with [18F]DPA-714 in progressive MS patients - [18F]DPA-714 PET in MS | Progressive multiple sclerosis, both primary and secondary progressive MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [18F]DPA-714 INN or Proposed INN: [18F]DPA-714 Other descriptive name: [18F]DPA-714 | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 511 | EUCTR2014-001081-99-BE (EUCTR) | 16/12/2014 | 03/12/2014 | A first in human trial for evaluating both safety and preliminary efficacy of a single infusion of stimulated autologous CD4+ cells in patients with Relapsing- Remitting multiple sclerosis | A clinical trial to document safety and radiological disease activity in patients with relapsing-remitting multiple sclerosis treated with autologous CD4+ cells, stimulated and expanded ex vivo by a myelin oligodendrocyte glycoprotein (MOG) peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope (SCLEROLYM trial).First-in-human trial - SCLEROLYM Trial | Multiple sclerosis is an immune-mediated inflammatory disease that attacks myelinated axons in the central nervous system. MS is characterized initially by episodes of reversible neurologic deficits. In most patients, these episodes are followed by progressive neurologic deterioration over time. Relapsing-remitting multiple sclerosis is characterized by recurrent attacks of neurologic dysfunction (relapses) followed by periods of complete or incomplete recovery (remission) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SCLEROLYM INN or Proposed INN: Cytolytic CD4+ T cells Other descriptive name: AUTOLOGOUS T-LYMPHOCYTES | ImCyse S.A | NULL | Not Recruiting | Female: yes Male: yes | Phase 1;Phase 2 | Belgium | |||
| 512 | EUCTR2014-001579-30-IT (EUCTR) | 04/12/2014 | 19/09/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 2 | Ukraine;Russian Federation;Netherlands;Germany;United Kingdom;Italy;United States;Canada;Spain | ||
| 513 | NCT02294058 (ClinicalTrials.gov) | December 3, 2014 | 5/8/2014 | Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS) | A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients | Multiple Sclerosis | Drug: Ozanimod;Drug: Interferon beta-1a;Drug: Placebo to ozanimod;Drug: Placebo to interferon beta-1a | Celgene | NULL | Completed | 18 Years | 55 Years | All | 1346 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Georgia;Germany;Hungary;Latvia;Lithuania;Moldova, Republic of;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom;Argentina;Austria;Colombia;Czech Republic;Mexico;Peru |
| 514 | EUCTR2013-003884-71-ES (EUCTR) | 01/12/2014 | 03/10/2014 | Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409 | A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ | Relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 799 | Phase 3B;Phase 4 | Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 515 | NCT02389426 (ClinicalTrials.gov) | December 2014 | 9/2/2015 | Transcranial Doppler in Multiple Sclerosis | Evaluation of Cerebrovascular Hemodynamics With Transcranial Doppler and Near-infrared Spectroscopy in Patients With Multiple Sclerosis | Multiple Sclerosis | Device: TCD baseline;Device: TCD after bosentan administration;Device: NIRS baseline;Device: NIRS after bosentan administration | Universitair Ziekenhuis Brussel | NULL | Completed | 18 Years | N/A | Both | 30 | N/A | Belgium |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 516 | EUCTR2014-001579-30-GB (EUCTR) | 27/11/2014 | 08/09/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) as compared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | |||
| 517 | EUCTR2014-002320-27-PT (EUCTR) | 21/11/2014 | 08/10/2014 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Peru;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Serbia;Belarus;United States;Portugal | ||
| 518 | EUCTR2014-002320-27-EE (EUCTR) | 21/11/2014 | 08/10/2014 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 519 | EUCTR2011-005677-23-EE (EUCTR) | 21/11/2014 | 22/10/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma Service AG | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | |||
| 520 | EUCTR2013-002378-26-SE (EUCTR) | 13/11/2014 | 15/08/2013 | Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes | Switch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext | The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial. MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera® Product Name: Mabthera | Västerbottens Läns Landsting | NULL | Not Recruiting | Female: yes Male: yes | 74 | Phase 2 | Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 521 | NCT02326935 (ClinicalTrials.gov) | November 2014 | 18/12/2014 | Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis | Proposal for a Non-randomized, Patient Sponsored, Multi-center Study Studying the Impact and Safety of the Utilization of Culture Expanded Autologous, Adipose-derived Mesenchymal Stem Cells Deployed Via Intravenous Injection for the Treatment of Multiple Sclerosis | Multiple Sclerosis | Biological: Autologous adipose derived mesenchymal cells | American CryoStem Corporation | NULL | Terminated | 18 Years | 65 Years | All | 2 | Phase 1 | Cayman Islands |
| 522 | NCT02253264 (ClinicalTrials.gov) | November 2014 | 29/9/2014 | A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients | A Phase 1 Open-label Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients With Magnetic Resonance Imaging Evidence of Leptomeningeal Enhancement | Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis | Drug: Rituximab | Johns Hopkins University | NULL | Completed | 18 Years | N/A | All | 8 | Phase 1 | United States |
| 523 | NCT02142764 (ClinicalTrials.gov) | November 2014 | 15/5/2014 | Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients | Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS). | Multiple Sclerosis | Biological: Blood samples | University Hospital, Bordeaux | Merck Serono International SA;ADERA | Completed | 18 Years | N/A | Both | 30 | N/A | France |
| 524 | NCT02259361 (ClinicalTrials.gov) | November 2014 | 1/10/2014 | Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS | Efficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot Study | Multiple Sclerosis | Drug: Sustained-release oral dalfampridine;Drug: Placebo | Sheba Medical Center | NULL | Not yet recruiting | 18 Years | 70 Years | Both | 30 | Phase 4 | Israel |
| 525 | EUCTR2014-003669-97-BE (EUCTR) | 27/10/2014 | 02/09/2014 | A safety study for patients with Relapsing Forms of Multiple Sclerosis who participated STRATA. | A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA. | Relapsing Forms of Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB | Biogen Idec | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 4 | Belgium | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 526 | EUCTR2014-001290-14-RO (EUCTR) | 24/10/2014 | 27/03/2017 | Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania using Electronic Device RebiSmart™ | Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania using Electronic Device RebiSmart™ - PROCEED | Clinical isolated syndrome and relapse multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: REBIF INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | MERCK ROMANIA SRL | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Romania | |||
| 527 | NCT02247310 (ClinicalTrials.gov) | October 20, 2014 | 19/9/2014 | BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon | BETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon® | Multiple Sclerosis, Relapsing Remitting | Drug: Interferon beta-1b (Betaferon®, BAY 86-5046);Device: BETACONNECT | Bayer | NULL | Completed | N/A | N/A | All | 498 | N/A | Austria;Belgium;Bosnia and Herzegovina;Croatia;Czechia;France;Greece;Hungary;Italy;Spain;Switzerland;Czech Republic;Netherlands |
| 528 | EUCTR2012-002714-40-HR (EUCTR) | 17/10/2014 | 05/11/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1410 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Slovenia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 529 | EUCTR2011-005677-23-RO (EUCTR) | 08/10/2014 | 30/05/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Belarus;United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 530 | EUCTR2013-003884-71-CZ (EUCTR) | 06/10/2014 | 11/08/2014 | Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409 | A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ | Relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1248 | Phase 3;Phase 4 | United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 531 | NCT02234869 (ClinicalTrials.gov) | October 2014 | 5/9/2014 | Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy | Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Patients With Relapsing Multiple Sclerosis Transitioning From Standard-of-care Subcutaneous Interferon Therapy to Peginterferon Beta-1a (BIIB017) | Relapsing Multiple Sclerosis | Drug: Interferon Beta;Drug: BIIB017 (Peginterferon beta-1a) | Biogen Idec | NULL | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 4 | NULL |
| 532 | NCT02205489 (ClinicalTrials.gov) | October 2014 | 29/7/2014 | Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA | Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA | Relapsing-remitting Multiple Sclerosis | Drug: Alemtuzumab GZ402673;Drug: cetirizine;Drug: ranitidine;Drug: methylprednisolone;Drug: aciclovir;Drug: esomeprazole;Drug: ibuprofen;Drug: paracetamol | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | Both | 58 | Phase 4 | Belgium;France;Netherlands;Spain |
| 533 | NCT02296346 (ClinicalTrials.gov) | October 2014 | 18/11/2014 | Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis | A Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS) | Secondary Progressive Multiple Sclerosis | Drug: SoluMedrol;Device: Extracorporeal Photopheresis | University of Utah | Mallinckrodt | Terminated | 18 Years | 75 Years | All | 13 | N/A | United States |
| 534 | NCT02280096 (ClinicalTrials.gov) | October 2014 | 10/10/2014 | Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis | Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis. Randomized, Blinded, Placebo-controlled Clinical Trial. | Multiple Sclerosis | Drug: 4-aminopyridine;Drug: Placebo | Coordinación de Investigación en Salud, Mexico | NULL | Completed | 18 Years | 60 Years | All | 24 | Phase 2 | Mexico |
| 535 | NCT02282826 (ClinicalTrials.gov) | October 2014 | 31/10/2014 | A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Intravenous and Subcutaneous Doses of GZ402668 in Men and Women With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: GZ402668;Drug: placebo;Drug: acyclovir | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 65 Years | Both | 48 | Phase 1 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 536 | EUCTR2011-005249-12-GB (EUCTR) | 29/09/2014 | 14/07/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | ||
| 537 | NCT02232061 (ClinicalTrials.gov) | September 29, 2014 | 2/9/2014 | Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod | Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod | Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 6 | Phase 4 | Belgium;Germany;Italy |
| 538 | EUCTR2013-001150-10-AT (EUCTR) | 16/09/2014 | 17/02/2014 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | neuromyelitis optica MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | ||
| 539 | EUCTR2014-000092-62-NL (EUCTR) | 04/09/2014 | 30/06/2014 | Management of the infusion-associated reactions in RRMS patients treated with Lemtrada | Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD | Relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 4 | France;Belgium;Spain;Netherlands;Switzerland | ||
| 540 | EUCTR2014-003209-14-FR (EUCTR) | 01/09/2014 | 18/06/2015 | ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS | ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS - TYSADIFF | MULTIPLE SCLEROSIS;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI 300 mg solution à diluer pour perfusion INN or Proposed INN: NATALIZUMAB | Hôpitaux Universitaires de Strasbourg | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 541 | NCT02282878 (ClinicalTrials.gov) | September 2014 | 31/10/2014 | The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis | The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis | Multiple Sclerosis | Dietary Supplement: High/Low Sodium Diet | Yale University | NULL | Active, not recruiting | 18 Years | 60 Years | All | 25 | N/A | United States |
| 542 | NCT02222948 (ClinicalTrials.gov) | September 2014 | 20/8/2014 | Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) | Relapsing-remitting Multiple Sclerosis | Drug: Vatelizumab;Drug: Placebo (for Vatelizumab) | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | 55 Years | Both | 112 | Phase 2 | United States;Canada;Poland;Russian Federation;Sweden |
| 543 | NCT02777060 (ClinicalTrials.gov) | September 2014 | 8/6/2015 | Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures | Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures | Diabetes;Cancer;Multiple Sclerosis;Arthritis;Parkinson's Disease;Cognitive Disorders;Brain Injury;Stroke | Procedure: Exergame;Procedure: Home based balance training | University of Arizona | NULL | Recruiting | 18 Years | N/A | Both | 200 | N/A | United States |
| 544 | NCT02273635 (ClinicalTrials.gov) | September 2014 | 3/10/2014 | Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS | Controlled, Randomized, Double-blind Clinical Trial, 24 Months Duration, to Compare the Efficacy, Safety and Tolerability of Andrographolide Versus Placebo in Patients With Progressive Forms of Multiple Sclerosis | Primary Progressive Multiple Sclerosis;Multiple Sclerosis, Secondary Progressive | Drug: Andrographolides;Drug: placebo | Innobioscience SpA | Pontificia Universidad Catolica de Chile;University of Chile;Universidad Austral de Chile | Recruiting | 18 Years | 70 Years | Both | 68 | Phase 1;Phase 2 | Chile |
| 545 | EUCTR2013-003752-21-PL (EUCTR) | 31/08/2014 | 04/07/2014 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120mg/vial) Product Code: Satralizumab (RO5333787/Enspryng /SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satrazlizumab (RO5333787/ Enspryng /SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;United States;Hungary;Taiwan;Spain;Poland;Ukraine;Germany;Japan;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 546 | EUCTR2014-000092-62-ES (EUCTR) | 28/08/2014 | 04/07/2014 | Management of the infusion-associated reactions in RRMS patients treated with Lemtrada | Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD | Relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 4 | France;Belgium;Spain;Netherlands;Switzerland | ||
| 547 | EUCTR2014-000092-62-FR (EUCTR) | 22/08/2014 | 18/06/2015 | Management of the infusion-associated reactions in RRMS patients treated with Lemtrada | Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD | Relapsing-remitting multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | France;Belgium;Spain;Netherlands;Switzerland | |||
| 548 | EUCTR2011-005677-23-NL (EUCTR) | 19/08/2014 | 25/02/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | United States;Estonia;Slovakia;Spain;Lithuania;Austria;United Kingdom;Italy;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Netherlands;Latvia;Germany;Sweden | ||
| 549 | EUCTR2011-005249-12-EE (EUCTR) | 13/08/2014 | 27/02/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | United States;Estonia;Greece;Canada;Spain;Belgium;Lebanon;Turkey;Australia;Russian Federation;Israel;China | |||
| 550 | EUCTR2011-005677-23-SE (EUCTR) | 07/08/2014 | 12/03/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 551 | NCT02073279 (ClinicalTrials.gov) | August 5, 2014 | 25/2/2014 | Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD) | Drug: Satralizumab;Drug: Placebo | Hoffmann-La Roche | Chugai Pharmaceutical | Active, not recruiting | 18 Years | 74 Years | All | 95 | Phase 3 | United States;Bulgaria;Canada;Croatia;Georgia;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Puerto Rico;Romania;Taiwan;Turkey;Ukraine;Bosnia and Herzegovina;Singapore |
| 552 | NCT02218879 (ClinicalTrials.gov) | August 2014 | 12/8/2014 | Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS | Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Tecfidera | Yale University | NULL | Terminated | 18 Years | 60 Years | Both | 7 | N/A | United States |
| 553 | NCT02209467 (ClinicalTrials.gov) | August 2014 | 4/8/2014 | Balance and Falls in Multiple Sclerosis | Balance and Falls in Multiple Sclerosis: Intervention and Perceptions From Patients and Next of Kins | Multiple Sclerosis | Other: Group balance training | Örebro County Council | NULL | Completed | 18 Years | N/A | Both | 52 | N/A | Sweden |
| 554 | EUCTR2014-000092-62-BE (EUCTR) | 30/07/2014 | 10/06/2014 | Management of the infusion-associated reactions in RRMS patients treated with Lemtrada | Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD | Relapsing-remitting multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 4 | France;Spain;Belgium;Netherlands;Switzerland | ||
| 555 | EUCTR2013-001439-34-GR (EUCTR) | 29/07/2014 | 23/04/2014 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Canada;Greece;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 556 | EUCTR2013-001151-12-AT (EUCTR) | 23/07/2014 | 14/02/2014 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | |||
| 557 | EUCTR2012-000835-18-PL (EUCTR) | 22/07/2014 | 06/06/2014 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Other descriptive name: Fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 558 | NCT02201108 (ClinicalTrials.gov) | July 16, 2014 | 17/7/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo | Genzyme, a Sanofi Company | NULL | Active, not recruiting | 10 Years | 17 Years | All | 166 | Phase 3 | United States;Belgium;Bulgaria;Canada;China;Estonia;France;Greece;Israel;Lebanon;Lithuania;Morocco;Netherlands;North Macedonia;Portugal;Russian Federation;Serbia;Slovenia;Spain;Tunisia;Turkey;Ukraine;United Kingdom;Australia;Macedonia, The Former Yugoslav Republic of;Poland |
| 559 | EUCTR2011-005677-23-GB (EUCTR) | 15/07/2014 | 12/03/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | |||
| 560 | EUCTR2011-005249-12-BE (EUCTR) | 11/07/2014 | 17/03/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;North Macedonia;Israel;France;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 561 | EUCTR2011-005249-12-GR (EUCTR) | 07/07/2014 | 21/05/2014 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis - TERIKIDS | Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | United States;Estonia;Greece;Spain;Lebanon;Turkey;Israel;Russian Federation;United Kingdom;Canada;Belgium;Australia;China | |||
| 562 | EUCTR2013-004533-32-PL (EUCTR) | 04/07/2014 | 05/05/2014 | A Study that evaluates the efficacy and safety of BG00012 in patients with RRMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 202 | Phase 3 | Czech Republic;Taiwan;Poland;Japan;Korea, Republic of | |||
| 563 | NCT02137044 (ClinicalTrials.gov) | July 2014 | 22/4/2014 | Multiple Sclerosis-Collaborative Approach to Rehabilitation Effectiveness Study | Improving the Quality of Care for Pain and Depression in Persons With Multiple Sclerosis | Multiple Sclerosis;Pain;Depression | Behavioral: Collaborative Care (CC) | University of Washington | Patient-Centered Outcomes Research Institute | Completed | 18 Years | N/A | All | 195 | N/A | United States |
| 564 | NCT02727907 (ClinicalTrials.gov) | July 2014 | 29/5/2015 | Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis | International, Multicenter, Double-blinded, Placebo-controlled, Randomized Study of the Efficacy and Safety of Drugs BCD-033 and Rebif for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: BCD-033 (interferon beta 1a);Drug: Rebif (interferon beta 1a);Drug: Placebo | Biocad | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 147 | Phase 2;Phase 3 | Russian Federation |
| 565 | NCT02159573 (ClinicalTrials.gov) | July 2014 | 19/5/2014 | Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab) | A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate) | Relapsing-Remitting Multiple Sclerosis | Biological: natalizumab;Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | Both | 530 | N/A | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 566 | NCT02121444 (ClinicalTrials.gov) | June 23, 2014 | 22/4/2014 | BAY86-5046 (Betaseron), Non Interventional Studies | BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon® | Multiple Sclerosis | Drug: Interferon beta-1b (Betaferon, BAY 86-5046);Device: BETACONNECT auto-injector. | Bayer | NULL | Completed | 18 Years | N/A | All | 151 | N/A | Germany |
| 567 | EUCTR2013-003126-83-DE (EUCTR) | 23/06/2014 | 17/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 568 | EUCTR2012-000835-18-DK (EUCTR) | 23/06/2014 | 09/05/2014 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 569 | EUCTR2013-002324-16-CZ (EUCTR) | 13/06/2014 | 08/01/2014 | Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis | A randomized, partially blind, placebo-controlled, proof-of-concept study to assess the effect of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: VAY736 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Czech Republic;Poland;Ukraine;Russian Federation | ||
| 570 | EUCTR2013-001656-35-CZ (EUCTR) | 11/06/2014 | 26/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Belgium;Spain;Austria;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 571 | EUCTR2013-001656-35-ES (EUCTR) | 06/06/2014 | 01/04/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera? (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | France;Portugal;Hungary;Czech Republic;Slovakia;Slovenia;Canada;Belgium;Spain;Austria;Italy | ||
| 572 | EUCTR2013-002324-16-PL (EUCTR) | 04/06/2014 | 09/04/2014 | Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis | A randomized, partially blind, placebo-controlled, proof-of-concept study to assess the effect of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: VAY736 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Czech Republic;Poland;Ukraine;Russian Federation | ||
| 573 | EUCTR2011-005249-12-ES (EUCTR) | 03/06/2014 | 01/04/2014 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis - TERIKIDS | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;China | |||
| 574 | EUCTR2012-002714-40-SK (EUCTR) | 02/06/2014 | 12/03/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 575 | NCT01941004 (ClinicalTrials.gov) | June 2014 | 9/9/2013 | Safety and Efficacy of Fingolimod in MS Patients in China | A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis (Relapsing Remitting) | Drug: fingolimod;Drug: Placebo (6mos) + open label fingolimod (6 mos) | Novartis Pharmaceuticals | NULL | Withdrawn | 18 Years | 50 Years | All | 0 | Phase 3 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 576 | NCT01883661 (ClinicalTrials.gov) | June 2014 | 12/6/2013 | Safety and Efficacy of BMMNC in Multiple Sclerosis (MS) | Role of Autologous Bone Marrow Derived Mono Nuclear Stem Cell (MNCs) In Patient With Multiple Sclerosis .It is Self Funded (Patients' Own Funding) Clinical Trial | Multiple Sclerosis | Biological: BMMNC | Chaitanya Hospital, Pune | NULL | Recruiting | 18 Years | 65 Years | Both | 15 | Phase 1;Phase 2 | India |
| 577 | NCT02064816 (ClinicalTrials.gov) | May 31, 2014 | 13/2/2014 | A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis | Multicenter, Open-label, 12 Week, Phase IV Prospective Randomized Study Aimed at Evaluating Whether sc IFN Beta 1a (Rebif®) Administered in the Morning May Affect the Severity of Flu-like Syndrome and Patient-perceived Invisible Symptoms in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Rebif® | Merck KGaA, Darmstadt, Germany | NULL | Completed | 18 Years | 60 Years | All | 200 | Phase 4 | Germany |
| 578 | EUCTR2012-002714-40-GB (EUCTR) | 29/05/2014 | 28/02/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | |||
| 579 | EUCTR2013-003126-83-GR (EUCTR) | 27/05/2014 | 25/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Denmark;Peru;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 580 | EUCTR2013-003126-83-ES (EUCTR) | 26/05/2014 | 05/03/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Serbia;Belarus;United States;United Arab Emirates;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 581 | EUCTR2013-002351-15-ES (EUCTR) | 26/05/2014 | 25/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Serbia;Portugal;Belarus;United States;United Arab Emirates;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Peru;Denmark;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 582 | EUCTR2013-001656-35-BE (EUCTR) | 26/05/2014 | 24/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 583 | EUCTR2013-003752-21-DE (EUCTR) | 22/05/2014 | 20/12/2013 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;United Kingdom | ||
| 584 | EUCTR2013-003126-83-HU (EUCTR) | 21/05/2014 | 21/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Denmark;Peru;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 585 | EUCTR2013-002351-15-BG (EUCTR) | 21/05/2014 | 20/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Interferon-ß-1a Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 586 | EUCTR2013-002351-15-HU (EUCTR) | 21/05/2014 | 21/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 587 | EUCTR2013-003752-21-GB (EUCTR) | 19/05/2014 | 15/10/2013 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;France;Taiwan;Hungary;Spain;Poland;Germany;Japan;Italy;United Kingdom | ||
| 588 | EUCTR2013-001151-12-FR (EUCTR) | 13/05/2014 | 25/09/2015 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing Neuromyelitis Optica MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 3 | United States;United Arab Emirates;Taiwan;Hong Kong;Saudi Arabia;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | |||
| 589 | EUCTR2013-001150-10-FR (EUCTR) | 13/05/2014 | 21/09/2015 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing neuromyelitis optica MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 3 | United States;United Arab Emirates;Taiwan;Hong Kong;Saudi Arabia;Spain;Chile;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | |||
| 590 | EUCTR2013-001656-35-SI (EUCTR) | 12/05/2014 | 09/05/2014 | A Study that evaluates effectiveness of Tecfidera™ (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovakia;Slovenia;Canada;Spain;Belgium;Austria;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 591 | EUCTR2013-002351-15-PT (EUCTR) | 09/05/2014 | 25/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Portugal;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 592 | EUCTR2013-001486-17-DE (EUCTR) | 06/05/2014 | 05/03/2014 | TOLERATE - A Study that evaluates the Gastrointestinal Tolerability of DMF in Multiple Sclerosis Patients | A Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects with Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE) | Relapsing-Remitting Multiple Sclerosis MedDRA version: 18.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 593 | EUCTR2013-001895-40-IE (EUCTR) | 02/05/2014 | 06/03/2014 | A study to evaluate the effect of aspirin on flushing in patients with RRMS treated with Tecfidera | A Phase 4, Randomized, Double-Blind Study with a Safety Extension Period to Evaluate the Effect of Aspirin on Flushing Events in Subjects with Relapsing-Remitting Multiple Sclerosis Treated with Tecfidera™ (dimethyl fumarate) delayed-release capsules (ASSURE) - ASSURE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Micropirin INN or Proposed INN: ACETYLSALICYLIC ACID Other descriptive name: ASA | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 4 | Ireland;United Kingdom | ||
| 594 | JPRN-JapicCTI-142447 | 01/5/2014 | 19/02/2014 | Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND) | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Intervention name : BAF312 INN of the intervention : Siponimod Dosage And administration of the intervention : BAF312 will be provided in a dose titration from 0.25 mg to a 2 mg dose. Control intervention name : Placebo Dosage And administration of the control intervention : Matching Placebo administered orally. | Novartis Pharma K.K. | NULL | complete | 18 | 60 | BOTH | 1530 | Phase 3 | NULL |
| 595 | NCT02143167 (ClinicalTrials.gov) | May 2014 | 9/5/2014 | Resistance Training and Amino Pyridine in Multiple Sclerosis | RETRAP - A Double Blind, Randomized, Placebo Controlled Study of the Effect of the Combination of Resistance Training and Prolonged Release Fampridine in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: SR-fampridine;Drug: Placebo | University of Southern Denmark | Region of Southern Denmark;Biogen | Completed | 18 Years | 60 Years | All | 40 | Phase 4 | Denmark |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 596 | NCT02579681 (ClinicalTrials.gov) | April 30, 2014 | 16/10/2015 | Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012 | Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012 | Multiple Sclerosis, Relapsing-Remitting | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | All | 221 | Phase 3 | Italy |
| 597 | EUCTR2013-004533-32-CZ (EUCTR) | 28/04/2014 | 08/01/2014 | A Study that evaluates the efficacy and safety of BG00012 in patients with RRMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 202 | Phase 3 | Taiwan;Czech Republic;Poland;Japan;Korea, Republic of | ||
| 598 | EUCTR2013-001656-35-SK (EUCTR) | 28/04/2014 | 10/03/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 599 | EUCTR2013-002283-25-PL (EUCTR) | 18/04/2014 | 21/01/2014 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 600 | EUCTR2013-003126-83-BG (EUCTR) | 16/04/2014 | 20/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Interferon-ß-1a Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Serbia;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 601 | EUCTR2013-001439-34-DE (EUCTR) | 15/04/2014 | 12/12/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden | |||
| 602 | EUCTR2013-001656-35-IT (EUCTR) | 14/04/2014 | 26/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | France;Portugal;Hungary;Czech Republic;Slovakia;Slovenia;Canada;Spain;Belgium;Austria;Italy | ||
| 603 | EUCTR2013-001656-35-PT (EUCTR) | 14/04/2014 | 25/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1080 | Phase 4 | France;Portugal;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Belgium;Spain;Austria;Italy | ||
| 604 | EUCTR2013-001656-35-HU (EUCTR) | 11/04/2014 | 21/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Czech Republic;Hungary;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 605 | NCT01892345 (ClinicalTrials.gov) | April 11, 2014 | 20/6/2013 | A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study) | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO) | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Drug: Eculizumab;Drug: Placebo | Alexion Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 143 | Phase 3 | United States;Argentina;Australia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Canada;Colombia;Czech Republic;France;Singapore |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 606 | EUCTR2013-002660-17-IT (EUCTR) | 09/04/2014 | 17/02/2014 | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS | multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolmod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Farma SpA | NULL | Not Recruiting | Female: yes Male: yes | 281 | Phase 2 | France;Portugal;Canada;Finland;Spain;Poland;Denmark;Germany;United Kingdom;Switzerland;Italy | ||
| 607 | EUCTR2013-001656-35-AT (EUCTR) | 07/04/2014 | 18/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 608 | EUCTR2013-001656-35-FR (EUCTR) | 07/04/2014 | 17/06/2015 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 609 | NCT02865018 (ClinicalTrials.gov) | April 2014 | 9/8/2016 | Neuromyelitis Optica (NMO) & Cetirizine | An Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis Optica | Neuromyelitis Optica | Drug: cetirizine | Icahn School of Medicine at Mount Sinai | Guthy Jackson Foundation | Completed | 18 Years | 85 Years | Both | 16 | Phase 1;Phase 2 | United States |
| 610 | NCT01933802 (ClinicalTrials.gov) | April 2014 | 23/8/2013 | Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple Sclerosis | Phase 1 Safety Study of Autologous Bone Marrow-derived Mesenchymal Stem Cell-derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo, Administered Intrathecally in Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: intrathecal administration of autologous MSC-NP | Tisch Multiple Sclerosis Research Center of New York | NULL | Completed | 18 Years | 70 Years | All | 20 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 611 | EUCTR2013-003752-21-IT (EUCTR) | 28/03/2014 | 06/02/2014 | A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 16.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SA237 INN or Proposed INN: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody | Chugai Pharmaceutical Co. Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;Hungary;Taiwan;Spain;Poland;Germany;United Kingdom;Japan;Italy | ||
| 612 | EUCTR2013-001439-34-AT (EUCTR) | 20/03/2014 | 09/01/2014 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden | |||
| 613 | EUCTR2013-001439-34-BE (EUCTR) | 19/03/2014 | 03/12/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | United States;Greece;Canada;Finland;Spain;Belgium;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden | |||
| 614 | EUCTR2013-002283-25-GB (EUCTR) | 18/03/2014 | 09/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 615 | EUCTR2013-002283-25-GR (EUCTR) | 18/03/2014 | 01/11/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 616 | EUCTR2013-002351-15-AT (EUCTR) | 13/03/2014 | 28/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 617 | EUCTR2013-004616-21-DE (EUCTR) | 13/03/2014 | 04/02/2014 | A study to assess immune function and typical disease characteristics in patients with multiple sclerosis, when switching from the medication Natalizumab to the medication Gilenya. | A 32-week, monocentric, exploratory, single arm study to assess immune function and MRI disease activity in patients with relapsing remitting multiple sclerosis (RRMS) transferred from previous treatment with Natalizumab to Gilenya® (Fingolimod) - ToFingo Successor | relapsing remitting multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB | Universitätsklinikum Münster | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 618 | EUCTR2013-002351-15-EE (EUCTR) | 13/03/2014 | 18/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 619 | EUCTR2013-002351-15-LV (EUCTR) | 03/03/2014 | 20/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 620 | NCT02325440 (ClinicalTrials.gov) | March 2014 | 4/9/2014 | Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya | A 32-week, Monocentric, Exploratory, Single Arm Study to Assess Immune Function and MRI Disease Activity in Patients With RRMS Transferred From Previous Treatment With Natalizumab to Gilenya® (Fingolimod) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Natalizumab | University Hospital Muenster | Novartis | Recruiting | 18 Years | 65 Years | Both | 15 | Phase 4 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 621 | NCT02137109 (ClinicalTrials.gov) | March 2014 | 1/5/2014 | Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri | Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Completed | N/A | 18 Years | Both | 400 | N/A | NULL |
| 622 | JPRN-JapicCTI-132397 | 20/2/2014 | 26/12/2013 | Efficacy and Safety Study as Add-on Therapy of SA237 to Treat NMO and NMOSD | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD) | Intervention name : SA237 INN of the intervention : satralizumab Dosage And administration of the intervention : subcutaneous administration of SA237 Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Chugai Pharmaceutical Co., Ltd. | F. Hoffmann-La Roche Ltd | complete | 12 | 74 | BOTH | 85 | Phase 3 | Japan, Asia except Japan, North America, Europe |
| 623 | NCT02028884 (ClinicalTrials.gov) | February 20, 2014 | 6/1/2014 | Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD) | Drug: Satralizumab;Drug: Placebo;Drug: Baseline Treatment | Hoffmann-La Roche | Chugai Pharmaceutical | Active, not recruiting | 12 Years | 74 Years | All | 83 | Phase 3 | United States;France;Germany;Hungary;Italy;Japan;Poland;Spain;Taiwan;Ukraine;United Kingdom |
| 624 | EUCTR2013-001150-10-GB (EUCTR) | 18/02/2014 | 25/07/2013 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Neuromyelitis Optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 625 | EUCTR2013-001151-12-GB (EUCTR) | 18/02/2014 | 25/07/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Russian Federation;Colombia;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 626 | EUCTR2013-001439-34-GB (EUCTR) | 17/02/2014 | 20/12/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;Switzerland;United Kingdom;Sweden | ||
| 627 | EUCTR2013-002283-25-BG (EUCTR) | 07/02/2014 | 04/12/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 628 | NCT02065284 (ClinicalTrials.gov) | February 2014 | 13/2/2014 | Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation in Patients With Multiple Sclerosis | Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation on Walking and Cortical Activation in Patients With Multiple Sclerosis. | Multiple Sclerosis;Ambulation Difficulty | Other: Rhythmic Auditory Stimulation (RAS) | The Cleveland Clinic | The Kelvin and Eleanor Smith Foundation;The Kelvin and Eleanor Smith Foundation | Completed | 18 Years | N/A | Both | 32 | N/A | United States |
| 629 | NCT03033355 (ClinicalTrials.gov) | February 2014 | 15/7/2016 | Central Nervous System Changes Following BotulinumtoxinA Injection in the Bladder | A Prospective Study of Higher Neural Control Changes Following Intradetrusor Injection of BotulinumtoxinA in Patients With Multiple Sclerosis and Lower Urinary Tract Symptoms. | Multiple Sclerosis;Lower Urinary Tract Symptoms;Neurogenic Bladder;Detrusor, Overactive;Urge Incontinence | Drug: Intradetrusor injection of Botulinum Toxin-A | Rose Khavari, M.D. | The Methodist Hospital System | Completed | 18 Years | N/A | Female | 28 | United States | |
| 630 | EUCTR2013-002283-25-ES (EUCTR) | 31/01/2014 | 06/11/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 631 | EUCTR2012-005450-30-SE (EUCTR) | 27/01/2014 | 10/12/2013 | Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatment | Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatment - ABIRISK | Development of neutralising antibodies against Interferon-beta in the treatment of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex Trade Name: Rebif Trade Name: Betaferon Trade Name: Extavia | Medizinische Universität Innsbruck | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Austria;Sweden | |||
| 632 | EUCTR2011-005677-23-AT (EUCTR) | 24/01/2014 | 19/12/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex Product Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 633 | EUCTR2011-005677-23-PL (EUCTR) | 13/01/2014 | 20/11/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 634 | EUCTR2012-005450-30-AT (EUCTR) | 08/01/2014 | 11/11/2013 | Investigation of neutralising antibodies against interferon-beta in patients with multiple sclerosis, in order to find markers to predict the development of these antibodies and minimize the risk of ineffective therapy | Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatment - ABIRISK | Development of neutralising antibodies against Interferon-beta in the treatment of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: Interferon-beta 1a Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a Other descriptive name: INTERFERON BETA-1A Trade Name: Betaferon INN or Proposed INN: Interferon-beta 1b Other descriptive name: INTERFERON BETA-1B Trade Name: Extavia INN or Proposed INN: Interferon-beta 1b Other descriptive name: INTERFERON BETA-1B Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a Other descriptive name: INTERFERON BETA-1A | Medizinische Universität Innsbruck | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Austria;Sweden | ||
| 635 | EUCTR2013-001439-34-IT (EUCTR) | 03/01/2014 | 16/10/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | United States;Greece;Finland;Spain;Austria;Chile;Italy;Switzerland;United Kingdom;Canada;Belgium;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 636 | NCT04265092 (ClinicalTrials.gov) | January 2014 | 22/10/2019 | Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis | Gaitox :Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis an Observational Study on Gait Spatiotemporal Parameters | Multiple Sclerosis | Drug: Incobotulinum toxin A | Pôle Saint Hélier | NULL | Completed | 18 Years | N/A | All | 22 | NULL | |
| 637 | NCT02034188 (ClinicalTrials.gov) | January 2014 | 9/1/2014 | Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis | Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: Umbilical cord mesenchymal stem cells | Translational Biosciences | NULL | Completed | 18 Years | 55 Years | All | 20 | Phase 1;Phase 2 | Panama |
| 638 | EUCTR2013-002283-25-HR (EUCTR) | 27/12/2013 | 02/09/2014 | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Male and female patients between the ages of 18 and 60 years with a current diagnosis of RRMS (according to the 2010 McDonald MS diagnostic criteria).;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: Plovamer acetate Other descriptive name: Plovamer acetate | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 639 | NCT02038049 (ClinicalTrials.gov) | December 20, 2013 | 14/1/2014 | A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis | A Randomized, Partially Blind, Placebo-controlled, Proof-of-concept Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity as Measured by Brain MRI Scans in Patients With Relapsing-remitting Multiple Sclerosis | Relapse Remitting Multiple Sclerosis | Drug: VAY736;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 55 Years | All | 8 | Phase 2 | United States;Czechia;Ukraine;Czech Republic;Germany;Poland;Russian Federation |
| 640 | EUCTR2013-002283-25-CZ (EUCTR) | 18/12/2013 | 26/09/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 641 | EUCTR2013-002558-64-IT (EUCTR) | 18/12/2013 | 16/10/2013 | improvement of cognitive performance after administration of fampridina in patients with multiple sclerosis | A randomised, placebo-controlled trial investigating the role of fampiridina in improving cognitive function of patients with multiple sclerosis. | MULTIPLE SCLEROSIS MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: fampyra Product Name: FAMPYRA INN or Proposed INN: FAMPRIDINE | dipartimento di neurologia e psichiatria | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 4 | Italy | ||
| 642 | EUCTR2011-005677-23-DE (EUCTR) | 16/12/2013 | 09/04/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 643 | EUCTR2013-001150-10-DE (EUCTR) | 12/12/2013 | 02/07/2013 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | Neuromyelitis Optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | ||
| 644 | EUCTR2013-001151-12-DE (EUCTR) | 12/12/2013 | 02/07/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 645 | EUCTR2013-002283-25-FI (EUCTR) | 09/12/2013 | 25/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 646 | NCT02047734 (ClinicalTrials.gov) | December 3, 2013 | 26/1/2014 | Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (Radiance Study) | A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients | Relapsing Multiple Sclerosis | Drug: Ozanimod 0.5 mg;Drug: Ozanimod 1 mg;Drug: Ozanimod placebo;Drug: Interferon ß-1a;Drug: IFN ß-1a placebo | Celgene | NULL | Completed | 18 Years | 55 Years | All | 1320 | Phase 3 | United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Georgia;Greece;Hungary;Italy;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom |
| 647 | NCT02146534 (ClinicalTrials.gov) | December 2013 | 23/4/2014 | Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients | Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: a Phase IV, Double-blind, Placebo-controlled Study. | Multiple Sclerosis | Drug: extended release fampridine;Drug: Placebo | Clinique Neuro-Outaouais | CogState Ltd. | Completed | 18 Years | N/A | All | 44 | Phase 4 | Canada |
| 648 | EUCTR2011-005677-23-BG (EUCTR) | 28/11/2013 | 15/11/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | Serbia;Belarus;United States;Venezuela, Bolivarian Republic of;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | |||
| 649 | EUCTR2013-002283-25-HU (EUCTR) | 25/11/2013 | 08/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 650 | EUCTR2013-001439-34-FI (EUCTR) | 18/11/2013 | 19/09/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 651 | EUCTR2013-001439-34-SE (EUCTR) | 17/11/2013 | 20/09/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden | ||
| 652 | EUCTR2013-001439-34-ES (EUCTR) | 15/11/2013 | 24/10/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | United States;Canada;Spain;Chile;Switzerland;Sweden | |||
| 653 | EUCTR2012-005086-12-BG (EUCTR) | 14/11/2013 | 19/08/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3b | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 654 | EUCTR2012-005086-12-DE (EUCTR) | 12/11/2013 | 01/07/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3b | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 655 | EUCTR2010-021219-17-PL (EUCTR) | 07/11/2013 | 16/07/2013 | A 96 weeks study to compare efficacy and safety of masitinib to placebo in the treatment of patients with primary progressiveor relapse free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib INN or Proposed INN: masitinb mesylate Other descriptive name: masitinib | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;Czech Republic;Slovakia;Greece;Spain;Poland;Romania;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 656 | EUCTR2012-004165-41-GB (EUCTR) | 04/11/2013 | 19/09/2013 | Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS | Inflammatory Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: natalizumab Trade Name: Fingolimod Product Name: Gilenya INN or Proposed INN: Fingolimod Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG-12 120 INN or Proposed INN: dimethyl fumarate | Northwestern University | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | United States;United Kingdom | ||
| 657 | NCT01968902 (ClinicalTrials.gov) | November 2013 | 21/10/2013 | Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis Patients | A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Incobotulinumtoxin Type A for the Functional Improvement of Lower Extremity Spasticity in Patients With Multiple Sclerosis | Muscle Spasticity;Multiple Sclerosis | Biological: incabotulinumtoxinA;Biological: Placebo | Multiple Sclerosis Center of Northeastern New York | Merz North America, Inc. | Completed | 18 Years | 65 Years | All | 27 | Phase 4 | United States |
| 658 | NCT01939002 (ClinicalTrials.gov) | November 2013 | 23/8/2013 | Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-ß) Therapies to Peginterferon Beta-1a (BIIB017) | An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017 | Relapsing Multiple Sclerosis | Drug: BIIB017;Drug: naproxen | Biogen | NULL | Completed | 18 Years | 65 Years | All | 251 | Phase 3 | United States |
| 659 | NCT03133403 (ClinicalTrials.gov) | November 2013 | 21/4/2016 | Hematopoietic Stem Cell Therapy for Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy | Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Tecfidera (BG12);Drug: Gilenya;Drug: Tysabri®;Drug: Avonex/Betaseron/Copaxone/Rebif;Procedure: Hematopoietic stem cell transplantation (HSCT) | Sheffield Teaching Hospitals NHS Foundation Trust | NULL | Recruiting | 18 Years | 55 Years | All | 5 | Phase 2;Phase 3 | United Kingdom |
| 660 | NCT02048358 (ClinicalTrials.gov) | November 2013 | 17/1/2014 | Safety, Pharmacokinetics and Pharmacodynamics Study With 2B3-201 in Healthy Subjects and Multiple Sclerosis(MS) Patients | Randomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201 | Healthy Volunteers;Multiple Sclerosis | Drug: 2B3-201;Drug: Placebo;Drug: Methylprednisolone hemisuccinate | BBB-Therapeutics B.V. | NULL | Terminated | 18 Years | 65 Years | Both | 47 | Phase 1 | Netherlands |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 661 | NCT01930708 (ClinicalTrials.gov) | October 31, 2013 | 15/8/2013 | A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | All | 1114 | Phase 4 | Austria;Belgium;Canada;Czechia;France;Hungary;Italy;Portugal;Slovakia;Slovenia;Spain;Czech Republic |
| 662 | EUCTR2013-002283-25-IT (EUCTR) | 29/10/2013 | 08/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 663 | EUCTR2013-001150-10-ES (EUCTR) | 17/10/2013 | 08/08/2013 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing neuromyelitis optica MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Italy;Switzerland;France;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Japan;Sweden | |||
| 664 | EUCTR2013-001151-12-ES (EUCTR) | 17/10/2013 | 08/08/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing Neuromyelitis Optica MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Japan;Sweden | ||
| 665 | EUCTR2012-004019-29-PL (EUCTR) | 07/10/2013 | 02/09/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | United States;Portugal;Finland;Spain;Turkey;Russian Federation;Colombia;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 666 | NCT01863888 (ClinicalTrials.gov) | October 2013 | 23/5/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: teriflunomide HMR1726;Drug: cholestyramine;Drug: charcoal | Sanofi | NULL | Completed | 18 Years | 55 Years | Both | 70 | Phase 3 | Belgium;Germany;Netherlands |
| 667 | NCT01986998 (ClinicalTrials.gov) | October 2013 | 11/1/2013 | Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse | Multicenter, Randomized, Double-blind Clinical Trial to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse. | Multiple Sclerosis | Drug: Methylprednisolone 1250 mg/24h x3 days;Drug: Oral Methylprednisolone 625 mg/24h x3 days | Germans Trias i Pujol Hospital | NULL | Completed | 18 Years | 59 Years | Both | 49 | Phase 4 | Spain |
| 668 | NCT02753088 (ClinicalTrials.gov) | October 2013 | 19/4/2016 | Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis | International, Multicentre, Double-blind, Placebo-controlled, Comparative, Randomized Study to Compare Efficacy and Safety of the Generic Drug BCD-063 (CJSC BIOCAD, Russia) and Copaxone®-Teva (Teva Pharmaceutical Industries Limited, Israel) in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: BCD-063;Drug: Copaxone-Teva;Drug: Placebo | Biocad | NULL | Completed | 18 Years | 55 Years | Both | 158 | Phase 3 | NULL |
| 669 | NCT01963611 (ClinicalTrials.gov) | October 2013 | 11/10/2013 | Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1) | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Plovamer acetate 0.5 milligram (mg);Drug: Copaxone 20 mg;Drug: Plovamer acetate 3 mg;Drug: Plovamer acetate 10 mg;Drug: Plovamer acetate 20 mg | EMD Serono | NULL | Terminated | 18 Years | 60 Years | All | 255 | Phase 2 | United States;Bulgaria;Croatia;Czech Republic;Finland;Greece;Hungary;Italy;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Turkey;Ukraine;United Kingdom;Germany |
| 670 | NCT01970410 (ClinicalTrials.gov) | October 2013 | 22/10/2013 | Sub-Study: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide - SWITCH-JCV | Switching Relapsing Multiple Sclerosis Patients Treated With Natalizumab at Risk for Progressive Multifocal Leukoencephalopathy to Teriflunomide: Is This Safe and Effective? (Sub-study: SWITCH-JCV) | Multiple Sclerosis | Drug: teriflunomide | Providence Health & Services | Multiple Sclerosis Center of Northeastern New York | Recruiting | 21 Years | 60 Years | All | 70 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 671 | EUCTR2012-000835-18-CZ (EUCTR) | 27/09/2013 | 17/06/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 672 | EUCTR2012-005324-16-NL (EUCTR) | 26/09/2013 | 03/05/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC | multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 68 | Belgium;Germany;Netherlands | |||
| 673 | EUCTR2011-006262-40-GB (EUCTR) | 24/09/2013 | 03/07/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | |||
| 674 | EUCTR2012-004019-29-DE (EUCTR) | 19/09/2013 | 06/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 675 | EUCTR2013-001150-10-IT (EUCTR) | 17/09/2013 | 09/07/2013 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - ECU-NMO-301 | Relapsing neuromyelitis optica MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | United States;United Arab Emirates;Taiwan;Saudi Arabia;Hong Kong;Spain;Russian Federation;Chile;Switzerland;Italy;France;Peru;Australia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Belgium;Brazil;Singapore;Germany;Japan;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 676 | EUCTR2013-001151-12-IT (EUCTR) | 17/09/2013 | 09/07/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - ECU-NMO-301 | Relapsing Neuromyelitis Optica MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;United Arab Emirates;Taiwan;Saudi Arabia;Hong Kong;Spain;Russian Federation;Chile;Colombia;Italy;France;Peru;Australia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Belgium;Brazil;Singapore;Germany;Japan;Sweden | ||
| 677 | EUCTR2012-005324-16-BE (EUCTR) | 27/08/2013 | 17/04/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC | multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 68 | Belgium;Germany;Netherlands | |||
| 678 | EUCTR2012-005262-35-GB (EUCTR) | 14/08/2013 | 11/06/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 679 | EUCTR2012-005262-35-IT (EUCTR) | 14/08/2013 | 25/06/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 680 | EUCTR2012-005324-16-DE (EUCTR) | 05/08/2013 | 06/06/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC | multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 68 | Belgium;Netherlands;Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 681 | EUCTR2012-002714-40-ES (EUCTR) | 02/08/2013 | 09/04/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden | ||
| 682 | EUCTR2012-004019-29-PT (EUCTR) | 02/08/2013 | 03/06/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 683 | JPRN-UMIN000010094 | 2013/08/01 | 01/04/2013 | A pilot study of Elaspol (Sivelestat Sodium) for neuromyelitis optica | neuromyelitis optica | 4.8mg/kg Sivelestat Sodium will administered constantly for 5 days in combination with 3 days intravenous methyl-prednisolone administration to sero-positive neuromyelitis optica patients who relapsed within 72 hours before starting treatment. | Tohoku University Hospital | NULL | Complete: follow-up complete | 20years-old | 55years-old | Male and Female | 10 | Phase 1;Phase 2 | Japan | |
| 684 | NCT01903291 (ClinicalTrials.gov) | August 2013 | 17/7/2013 | Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS | A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate | Relapsing Forms of Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | Both | 333 | N/A | United States |
| 685 | NCT02225977 (ClinicalTrials.gov) | July 31, 2013 | 24/8/2014 | Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya. | Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya. | Multiple Sclerosis | Drug: Gilenya | University of Southern California | NULL | Completed | 18 Years | 65 Years | All | 125 | United States | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 686 | EUCTR2012-005086-12-HU (EUCTR) | 31/07/2013 | 18/06/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3b | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 687 | NCT01892722 (ClinicalTrials.gov) | July 26, 2013 | 8/5/2013 | Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis | A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon ß-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase | Multiple Sclerosis | Drug: Interferon beta-1a;Drug: Fingolimod;Drug: Placebo capsule;Drug: Placebo i.m. injection | Novartis Pharmaceuticals | NULL | Recruiting | 10 Years | 17 Years | All | 245 | Phase 3 | United States;Australia;Austria;Belarus;Brazil;Bulgaria;Canada;Croatia;Estonia;France;Germany;Italy;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;South Africa |
| 688 | EUCTR2012-005262-35-AT (EUCTR) | 19/07/2013 | 02/04/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 468 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 689 | EUCTR2012-004019-29-CZ (EUCTR) | 18/07/2013 | 13/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 690 | EUCTR2012-004807-10-DE (EUCTR) | 17/07/2013 | 26/10/2012 | Relapse Escalation treatment trial in Optic Neuritis (RESCON):Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis | Relapse Escalation treatment trial in Optic Neuritis (RESCON):Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis | MS patients who suffer from severe Optic Neuritis without satisfying improvement after treatment with steroids (3-5 days with 1 g daily at least 7 days prior to randomization) and with persisting visual acuity < 0.7, duration of symptoms should be = 4 weeks MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Urbason® solubile forte 1000 mg Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE | University Medical Center Hamburg Eppendorf | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 691 | EUCTR2012-004019-29-IT (EUCTR) | 10/07/2013 | 11/01/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebocontrolled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2 | United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;Canada;Argentina;Poland;Germany;Japan;Sweden | ||
| 692 | EUCTR2012-005262-35-SI (EUCTR) | 10/07/2013 | 10/07/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 468 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 693 | EUCTR2012-002714-40-GR (EUCTR) | 10/07/2013 | 17/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 16.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden | ||
| 694 | EUCTR2012-005086-12-AT (EUCTR) | 05/07/2013 | 08/05/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3b | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 695 | EUCTR2011-006262-40-NL (EUCTR) | 03/07/2013 | 10/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 INN or Proposed INN: PRD806998 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 696 | NCT02076841 (ClinicalTrials.gov) | July 2013 | 19/2/2014 | Tolerability and Quality of Life Study in Participants Who Switched to Avonex Pen | Tolerability and Quality of Life in Patients With Multiple Sclerosis Switched to Intramuscular Interferon Beta 1a Autoinjector (Avonex® PenTM) | Relapsing-Remitting Multiple Sclerosis;Clinical Isolated Syndrome (CIS);Multiple Sclerosis | Device: interferon beta-1a | Biogen | NULL | Completed | 18 Years | N/A | All | 40 | N/A | Czech Republic;Switzerland |
| 697 | NCT01900093 (ClinicalTrials.gov) | July 2013 | 11/7/2013 | Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses | An Open-Label Prospective Proof-Of-Concept Trial to Evaluate the Response to Acthar Gel Therapy in Patients With Multiple Sclerosis (MS) Relapses Who Have Failed To Make an Adequate Recovery After Treatment With High-Dose Intravenous Methylprednisolone | Multiple Sclerosis | Drug: Acthar Gel | Aaron Miller | Mallinckrodt | Recruiting | 18 Years | 65 Years | All | 10 | N/A | United States |
| 698 | NCT02048072 (ClinicalTrials.gov) | July 2013 | 27/1/2014 | Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS | Funktionelle Evaluation Des Autonomen Nervensystems im Zusammenhang Mit Der Erstmaligen Einnahme Von 0,5mg Fingolimod (Gilenya) Bei Patienten Mit schubförmig Verlaufender Multipler Sklerose | Multiple Sclerosis;Autonomic Nervous System Dysfunction | Drug: Gilenya | Jochen Vehoff | NULL | Completed | 18 Years | 60 Years | All | 33 | Phase 4 | Switzerland |
| 699 | EUCTR2012-005262-35-ES (EUCTR) | 28/06/2013 | 13/06/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 700 | EUCTR2011-006262-40-ES (EUCTR) | 28/06/2013 | 13/06/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 INN or Proposed INN: No disponible Other descriptive name: Anticuerpo monoclonal anti-LINGO-1 humano Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | France;United States;Serbia;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 701 | EUCTR2012-004019-29-SE (EUCTR) | 19/06/2013 | 12/04/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 702 | EUCTR2012-004019-29-FI (EUCTR) | 19/06/2013 | 16/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 703 | EUCTR2012-005262-35-FI (EUCTR) | 18/06/2013 | 25/04/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 704 | EUCTR2011-006262-40-CZ (EUCTR) | 18/06/2013 | 05/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 705 | EUCTR2012-005262-35-CZ (EUCTR) | 13/06/2013 | 26/03/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 706 | EUCTR2013-001422-25-IT (EUCTR) | 11/06/2013 | 17/04/2013 | Study to be conducted only in Italy to evaluate the effect of the treatment with BG00012 on cognitive function in patients with Relapsing Remitting Multiple Sclerosis | Single country study assessing cognition in Relapsing Remitting Multiple Sclerosis patients treated with BG00012 | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: dimethyl fumarate [DMF] Product Code: BG00012 INN or Proposed INN: dimetilfumarato Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Italia S.r.l. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | Italy | ||
| 707 | EUCTR2012-002714-40-HU (EUCTR) | 10/06/2013 | 02/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 708 | EUCTR2011-006262-40-HU (EUCTR) | 06/06/2013 | 25/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 INN or Proposed INN: Not available Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Czech Republic;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 709 | JPRN-JapicCTI-132178 | 01/6/2013 | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Intervention name : AIN457 INN of the intervention : secukinumab Dosage And administration of the intervention : AIN457 will be administered intravenously. Patients will be randomized to AIN457 Low/Middle/High dose. Control intervention name : Placebo Dosage And administration of the control intervention : Matching placebo will be administered intravenously. | Novartis Pharma K.K. | NULL | 18 | 55 | BOTH | 380 | Phase 2 | NULL | ||
| 710 | EUCTR2011-006262-40-IT (EUCTR) | 01/06/2013 | 08/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 396 | United States;Serbia;Hungary;Czech Republic;Canada;Spain;Russian Federation;Netherlands;United Kingdom;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 711 | NCT03216915 (ClinicalTrials.gov) | June 1, 2013 | 22/6/2017 | Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis | FINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Gilenya®; Novartis Pharmaceuticals Corporation | Universitätsklinikum Hamburg-Eppendorf | NULL | Recruiting | 18 Years | N/A | All | 100 | Germany | |
| 712 | NCT01895335 (ClinicalTrials.gov) | June 2013 | 3/7/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients | Multiple Sclerosis | Drug: Teriflunomide | Sanofi | NULL | Completed | 18 Years | N/A | All | 1001 | Phase 4 | United States;Austria;Belgium;Canada;Chile;Finland;France;Germany;Greece;Italy;Norway;Spain;Sweden;United Kingdom |
| 713 | NCT01717664 (ClinicalTrials.gov) | June 2013 | 24/10/2012 | Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis (RRMS) | A Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of Fixed Dose Combination RHB-104 as Add-On Therapy to Interferon Beta-1a in Patients Treated for Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: RHB-104 | RedHill Biopharma Limited | NULL | Completed | 18 Years | N/A | Both | 18 | Phase 2 | Israel |
| 714 | NCT01874340 (ClinicalTrials.gov) | June 2013 | 28/5/2013 | Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: AIN457 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 55 Years | All | 28 | Phase 2 | Belgium;Czech Republic;France;Italy;Japan;Poland;Russian Federation;Spain;Sweden;Turkey;Canada;Finland;Germany;Romania;Switzerland;United States |
| 715 | NCT01621269 (ClinicalTrials.gov) | June 2013 | 24/4/2012 | ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon | A 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Fingolimod in the Treatment of Relapsing-remitting Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta | Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 4 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 716 | EUCTR2012-003056-36-IE (EUCTR) | 31/05/2013 | 06/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 717 | EUCTR2012-004040-30-AT (EUCTR) | 24/05/2013 | 12/03/2013 | Natalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter study | Natalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter study | relapse-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BETAFERON® (interferon beta-1b) Product Name: Betaferon INN or Proposed INN: Betaferon Other descriptive name: INTERFERON BETA-1B | Ospedale Regionale di Lugano | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Austria;Switzerland | |||
| 718 | EUCTR2012-004019-29-ES (EUCTR) | 24/05/2013 | 24/06/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 719 | EUCTR2012-002714-40-BG (EUCTR) | 17/05/2013 | 08/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;South Africa;Moldova, Republic of;Bosnia and Herzegovina | ||
| 720 | EUCTR2011-005677-23-LT (EUCTR) | 10/05/2013 | 11/02/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 721 | EUCTR2012-002714-40-IT (EUCTR) | 09/05/2013 | 08/03/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Belgium;Croatia;Georgia;Bulgaria | ||
| 722 | NCT01873417 (ClinicalTrials.gov) | May 2013 | 9/5/2013 | Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States | A Multicenter, Open-Label, Single-Arm Study of Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera™ (Dimethyl Fumarate) Delayed-release Capsules | Relapsing Forms of Multiple Sclerosis | Drug: BG00012 (DMF) | Biogen | NULL | Completed | 18 Years | N/A | All | 237 | Phase 4 | United States |
| 723 | NCT01845584 (ClinicalTrials.gov) | May 2013 | 26/4/2013 | Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy. | NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy. | Neuromyelitis Optica Spectrum Disorder | Drug: NPB-01 | Nihon Pharmaceutical Co., Ltd | NULL | Completed | 20 Years | N/A | All | 7 | Phase 2 | Japan |
| 724 | EUCTR2012-004019-29-BE (EUCTR) | 29/04/2013 | 23/10/2012 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan;Sweden | ||
| 725 | EUCTR2012-002714-40-BE (EUCTR) | 29/04/2013 | 14/03/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Sweden;Bosnia and Herzegovina | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 726 | EUCTR2011-005677-23-LV (EUCTR) | 29/04/2013 | 19/03/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase. | Relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Belarus;United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | |||
| 727 | EUCTR2011-005677-23-ES (EUCTR) | 26/04/2013 | 09/04/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Farmaceutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | United States;Venezuela, Bolivarian Republic of;Mexico;Canada;Brazil;Spain;Lithuania;Latvia | |||
| 728 | EUCTR2012-004436-36-DK (EUCTR) | 19/04/2013 | 22/04/2013 | Effect of rituximab in secondary progressive multiple sclerosis | A prospective pilotstudy of immunological and radiological effects of intrathecal rituximab in patients with secondary progressive multiple sclerosis | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabThera (Rituximab) Product Name: MabThera INN or Proposed INN: RITUXIMAB | Odense University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Denmark | ||
| 729 | EUCTR2012-005507-40-IT (EUCTR) | 15/04/2013 | 25/02/2013 | Study to provide access to fingolimod to Multiple Sclerosis patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drug | An open-label, single arm study to provide access to fingolimod to MS patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drug | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD HYDROCHLORIDE | NOVARTIS FARMA S.p.A | NULL | Not Recruiting | Female: yes Male: yes | Phase 3b | Italy | |||
| 730 | EUCTR2012-000835-18-HU (EUCTR) | 15/04/2013 | 28/02/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 731 | EUCTR2012-003056-36-GB (EUCTR) | 08/04/2013 | 02/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 732 | EUCTR2011-005677-23-IT (EUCTR) | 02/04/2013 | 11/02/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 15.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Farma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | United States;Venezuela, Bolivarian Republic of;Mexico;Canada;Spain;Brazil;Lithuania;Latvia;Italy | |||
| 733 | NCT01816100 (ClinicalTrials.gov) | April 2013 | 25/2/2013 | The Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis Patients | The Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis Patients: A Multimodal Neuroimaging Investigation | Multiple Sclerosis | Other: specifically design 6 month resistance training program;Behavioral: 6 months weight resistance and balance program | University of Nebraska | Biogen | Completed | 19 Years | 65 Years | Both | 6 | N/A | United States |
| 734 | NCT01808885 (ClinicalTrials.gov) | April 2013 | 12/2/2013 | Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta. | A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta. | Relapsing Remitting Multiple Sclerosis | Drug: olesoxime (TRO19622);Drug: placebo | Hoffmann-La Roche | Hôpital de la Timone;SGS S.A.;STRAGEN Services | Completed | 18 Years | N/A | Both | 44 | Phase 1 | France |
| 735 | EUCTR2011-005677-23-SK (EUCTR) | 27/03/2013 | 04/03/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase - PARADIGMS | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 736 | EUCTR2012-003056-36-BG (EUCTR) | 20/03/2013 | 06/02/2013 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 737 | EUCTR2010-021219-17-GR (EUCTR) | 19/03/2013 | 30/01/2013 | A clinical study to compare the efficacy and safety of masitinib 4.5 mg/kg/day vs. placebo in the treatment of patients with multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Slovakia;Greece;Poland;Spain;Turkey;Bulgaria;Germany | |||
| 738 | EUCTR2012-000835-18-NL (EUCTR) | 19/03/2013 | 03/01/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | |||
| 739 | EUCTR2012-003056-36-PL (EUCTR) | 18/03/2013 | 20/12/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 740 | EUCTR2012-000835-18-GB (EUCTR) | 18/03/2013 | 09/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 741 | NCT01808482 (ClinicalTrials.gov) | March 13, 2013 | 7/3/2013 | A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | A First Time in Human Study Exploring Preliminary Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Part A: 100 mg/mL GSK2618960;Drug: Part A: matching placebo;Drug: Part B: Dose of GSK2618960 decided from Part A;Drug: Part B: matching placebo;Drug: Part C: Dose of GSK2618960 decided from Part A and B | GlaxoSmithKline | NULL | Terminated | 18 Years | 55 Years | Male | 16 | Phase 1 | United Kingdom |
| 742 | EUCTR2011-002959-34-DK (EUCTR) | 11/03/2013 | 01/03/2013 | RETRAP - A study of the effect of combination of resistance training and prolonged-release fampridine on muscle strength in the legs, walking capacity and quality of life in multiple sclerosis patients. | RETRAP - A double blind, randomized, placebo controlled study of the effect of the combination of resistance training and prolonged release fampridine on muscle strength in the lower extremities, walking capacity and quality of life in relapsing remitting multiple sclerosis - RETRAP | Multiple sclerosis MedDRA version: 15.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampyra INN or Proposed INN: FAMPRIDINE | Sønderjylland Hospital, department of neurology | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 4 | Denmark | ||
| 743 | EUCTR2012-000957-30-GB (EUCTR) | 05/03/2013 | 12/12/2012 | BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple Sclerosis | BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis | Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum Toxin Type A | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 184 | France;United States;Portugal;Czech Republic;Canada;Belgium;Poland;Russian Federation;United Kingdom | |||
| 744 | EUCTR2010-020338-25-NL (EUCTR) | 02/03/2013 | 30/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | |||
| 745 | NCT01803867 (ClinicalTrials.gov) | March 2013 | 26/2/2013 | An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis | A Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of Recombinant Human Immunoglobulin M (rHIgM22) in Patients With Multiple Sclerosis (MS) | Multiple Sclerosis | Drug: rHIgM22 | Acorda Therapeutics | PRA Health Sciences | Completed | 18 Years | 70 Years | Both | 72 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 746 | NCT01791244 (ClinicalTrials.gov) | February 28, 2013 | 12/2/2013 | A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device | A Phase IV Multicenter Randomized Study to Assess the Impact of a Patient Support Program (MinSupport Plus) on Health Related Quality of Life (HRQoL) and Adherence in Patients With Relapsing Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart Device | Multiple Sclerosis;Relapsing-Remitting | Drug: Rebif® | Merck KGaA | NULL | Completed | 18 Years | N/A | All | 93 | Phase 4 | Germany;Sweden |
| 747 | EUCTR2012-000835-18-DE (EUCTR) | 26/02/2013 | 06/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 748 | EUCTR2011-000985-36-ES (EUCTR) | 22/02/2013 | 25/01/2012 | Study on the Use of surface electromyography in the detection of objective differencies in patients with spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex | Study on the Use of surface electromyography in the detection of objective differencies in patients with spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex | Spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex MedDRA version: 14.1;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: SATIVEX Product Name: sativex Product Code: N02BG10 INN or Proposed INN: pending Other descriptive name: CANNABIDIOL | JOSE MANUEL GARCIA DOMINGUEZ | NULL | Not Recruiting | Female: yes Male: yes | Spain | ||||
| 749 | NCT01707992 (ClinicalTrials.gov) | February 20, 2013 | 28/9/2012 | The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: Laquinimod;Drug: Placebo | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | 55 Years | All | 2199 | Phase 3 | United States;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Montenegro;North Macedonia;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom;Czech Republic;Kazakhstan;Macedonia, The Former Yugoslav Republic of;Mexico;Portugal |
| 750 | EUCTR2012-000411-91-DE (EUCTR) | 13/02/2013 | 04/12/2012 | Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod | Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod: a monocentric, prospective, one year, baseline-to-treatment, open-label, single group pilot trial - NKZellen-Version1.0 | relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya® Product Name: Gilenya® Product Code: Gilenya® INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | Charité - Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 751 | NCT02040116 (ClinicalTrials.gov) | February 2013 | 14/1/2014 | Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases | Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases | Multiple Sclerosis | Drug: Rituximab Infusion | Wake Forest University Health Sciences | NULL | Completed | 18 Years | 80 Years | All | 19 | Phase 4 | United States |
| 752 | EUCTR2012-000957-30-PT (EUCTR) | 29/01/2013 | 12/11/2012 | BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple Sclerosis | BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis | Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum Toxin Type A | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 184 | France;United States;Portugal;Czech Republic;Canada;Belgium;Poland;Russian Federation;United Kingdom | |||
| 753 | EUCTR2012-004183-21-GB (EUCTR) | 25/01/2013 | 14/12/2012 | Melatonin for Nocturia in patients with Multiple Sclerosis | A randomized, double blind, placebo controlled, cross over trial of Melatonin for the treatment of nocturia in adults with progressive multiple sclerosis, with an open label, single-arm extension study - Melatonin for Nocturia in MS | Nocturia; Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | North Bristol NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United Kingdom | |||
| 754 | EUCTR2012-000835-18-ES (EUCTR) | 23/01/2013 | 29/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 15.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GYLENIA 0,5 mg Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Farmaceutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Finland;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Sweden | |||
| 755 | EUCTR2012-003056-36-BE (EUCTR) | 21/01/2013 | 19/11/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 756 | EUCTR2012-000835-18-BE (EUCTR) | 18/01/2013 | 19/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 757 | EUCTR2012-003056-36-GR (EUCTR) | 15/01/2013 | 23/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 758 | EUCTR2012-000835-18-IT (EUCTR) | 12/01/2013 | 19/12/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: FINGOLIMOD HYDROCHLORIDE | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;Sweden | |||
| 759 | NCT01753375 (ClinicalTrials.gov) | January 2013 | 17/12/2012 | Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis | Role of Vitamin D on the Relapse Rate of Multiple Sclerosis | Multiple Sclerosis | Dietary Supplement: Vitamin D3;Dietary Supplement: Placebo | AlJohara M AlQuaiz, M.D. | NULL | Not yet recruiting | 18 Years | 55 Years | Both | 200 | Phase 2 | Saudi Arabia |
| 760 | NCT01755871 (ClinicalTrials.gov) | January 2013 | 19/12/2012 | Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis | The Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod | Heinrich-Heine University, Duesseldorf | Novartis Pharmaceuticals | Terminated | 18 Years | 65 Years | Both | 8 | Phase 4 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 761 | NCT01779934 (ClinicalTrials.gov) | January 2013 | 26/10/2012 | OL, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis | Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: FTY720 | Novartis Pharmaceuticals | NULL | Completed | 28 Years | N/A | Both | 579 | Phase 3 | United States;Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 762 | EUCTR2012-003056-36-LT (EUCTR) | 21/12/2012 | 29/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 763 | EUCTR2012-000835-18-FR (EUCTR) | 20/12/2012 | 19/06/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 764 | NCT01665144 (ClinicalTrials.gov) | December 20, 2012 | 3/8/2012 | Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND) | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312. | Secondary Progressive Multiple Sclerosis | Drug: BAF312;Drug: Placebo | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 60 Years | All | 1653 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;China;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Latvia;Lithuania;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Egypt |
| 765 | EUCTR2012-003056-36-LV (EUCTR) | 18/12/2012 | 18/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 766 | EUCTR2012-003056-36-DE (EUCTR) | 14/12/2012 | 11/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 767 | EUCTR2012-003056-36-EE (EUCTR) | 13/12/2012 | 09/11/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | |||
| 768 | EUCTR2012-003056-36-SE (EUCTR) | 12/12/2012 | 08/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 769 | EUCTR2012-003056-36-PT (EUCTR) | 11/12/2012 | 11/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | |||
| 770 | EUCTR2012-003056-36-SK (EUCTR) | 10/12/2012 | 13/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 771 | NCT01766063 (ClinicalTrials.gov) | December 6, 2012 | 7/12/2012 | Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on Betaferon | BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients | Multiple Sclerosis | Drug: Interferon beta-1b (Betaferon, BAY 86-5046) | Bayer | NULL | Completed | 18 Years | N/A | All | 138 | Germany | |
| 772 | EUCTR2012-003056-36-ES (EUCTR) | 04/12/2012 | 02/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Farmacéutica S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Australia;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Sweden | |||
| 773 | NCT01720849 (ClinicalTrials.gov) | December 2012 | 31/10/2012 | Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, Cognition, Fatigue and Micturation in Patients With Multiple Sclerosis | Multiple Sclerosis;EDSS 4-7 | Drug: Fampyra | Vestre Viken Hospital Trust | NULL | Recruiting | 18 Years | N/A | Both | 50 | N/A | Norway | |
| 774 | NCT01272128 (ClinicalTrials.gov) | December 2012 | 6/1/2011 | Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL Study | A Multicenter, Prospective Non-interventional Study to Evaluate the Quality of Life in Belgian Patients With CIS or RRMS in Whom Interferon Beta-1a IM Treatment Has Been Initiated | Multiple Sclerosis | Drug: Interferon beta-1a | Biogen | NULL | Completed | 18 Years | N/A | Both | 100 | N/A | Belgium;United States |
| 775 | NCT01764737 (ClinicalTrials.gov) | December 2012 | 3/1/2013 | Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients With MS | A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study Of The Safety, Tolerability, And Pharmacokinetics Of Intravenous VX15/2503 In Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: VX15/2503;Drug: Placebo | Vaccinex Inc. | PRA Health Sciences | Completed | 18 Years | 60 Years | Both | 50 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 776 | EUCTR2012-000835-18-FI (EUCTR) | 28/11/2012 | 08/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 777 | EUCTR2012-003056-36-AT (EUCTR) | 28/11/2012 | 08/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 778 | EUCTR2012-003056-36-IT (EUCTR) | 21/11/2012 | 15/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate | NOVARTIS FARMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Portugal;United States;Estonia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Australia;Bulgaria;Latvia;Germany;Sweden | |||
| 779 | EUCTR2012-003056-36-CZ (EUCTR) | 08/11/2012 | 12/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | |||
| 780 | EUCTR2012-000835-18-SE (EUCTR) | 07/11/2012 | 01/10/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 781 | EUCTR2012-001965-34-ES (EUCTR) | 07/11/2012 | 09/08/2012 | Study to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse. | Multicenter, randomized, double-blind clinical trial to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse. | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Urbason 40 mg Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE | Servicio de Neurología, HU. Germans Trias i Pujol | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Spain | |||
| 782 | NCT01728922 (ClinicalTrials.gov) | November 6, 2012 | 8/11/2012 | Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome | Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome and Healthy Control Participants. An Exploratory Double Blind Placebo Randomised Controlled Study. | Clinically Isolated Syndrome;Multiple Sclerosis | Dietary Supplement: 5000IU vitamin D;Dietary Supplement: 10000IU vitamin D;Other: Placebo | University College Dublin | University of Dublin, Trinity College;St Vincent's University Hospital, Ireland | Completed | 18 Years | 55 Years | All | 64 | Phase 1;Phase 2 | Ireland |
| 783 | NCT01744444 (ClinicalTrials.gov) | November 2012 | 30/11/2012 | Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis | Pendular Nystagmus Patients With Multiple Sclerosis | Drug: Memantine;Drug: Gabapentin | Hospices Civils de Lyon | NULL | Completed | 18 Years | N/A | Both | 10 | Phase 2 | France | |
| 784 | NCT02137707 (ClinicalTrials.gov) | November 2012 | 12/5/2014 | Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya | An Investigator-initiated, Multicenter, Phase IV, Open-label Study to Evaluate the Biological Basis for Disease Progression in Relapsing-remitting Multiple Sclerosis Patients Treated in Routine Practice With Gilenya for 2 Years | Multiple Sclerosis-Relapsing-Remitting | Drug: Gilenya | McGill University | Novartis | Completed | 18 Years | 65 Years | All | 135 | Phase 4 | Canada |
| 785 | NCT01743651 (ClinicalTrials.gov) | November 2012 | 28/11/2012 | Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis | A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis | Spasticity;Multiple Sclerosis | Drug: arbaclofen;Drug: baclofen;Drug: Placebo | Osmotica Pharmaceutical Corp. | NULL | Completed | 18 Years | 65 Years | Both | 353 | Phase 3 | United States;Russian Federation;Ukraine |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 786 | NCT01767493 (ClinicalTrials.gov) | November 2012 | 13/12/2012 | Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients | An Open-label, Non-randomized Study to Evaluate the Feasibility of [18F]Florbetapir Positron Emission Tomography (PET) for Assessment of Demyelination in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: [18F]Florbetapir and PET imaging | Institute for Neurodegenerative Disorders | Biogen Idec | Recruiting | 18 Years | 60 Years | Both | 18 | N/A | United States |
| 787 | EUCTR2012-003056-36-HU (EUCTR) | 31/10/2012 | 03/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | |||
| 788 | EUCTR2010-020315-36-CZ (EUCTR) | 18/10/2012 | 22/08/2012 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 789 | EUCTR2012-002637-11-DE (EUCTR) | 15/10/2012 | 09/10/2012 | A 6 months, multicenter study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis | A 6 months, randomized, multicenter, parallel-group, open-label study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis - STAY | Treatment statisfaction in patients with relapsing remitting Multiple Sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: Fingolimod Hydrochloride | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 790 | EUCTR2012-002694-66-FI (EUCTR) | 12/10/2012 | 08/10/2012 | Effect of fingolimod on cardiac autonomic regulation in MS-patients | Effect of fingolimod on cardiac autonomic regulation in MS-patients | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Sakari Simula | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Finland | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 791 | NCT01895439 (ClinicalTrials.gov) | October 2012 | 24/6/2013 | Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple Sclerosis | Phase II Study: Use of Autologus Mesenchymal Stem Cells in Multiple Sclerosis Patients Who do Not Respond to Conventional Treatment | Multiple Sclerosis | Biological: Autologous Mesenchymal Stem Cells | University of Jordan | NULL | Completed | 18 Years | 65 Years | All | 13 | Phase 1;Phase 2 | Jordan |
| 792 | NCT01578330 (ClinicalTrials.gov) | October 2012 | 16/3/2012 | A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720 | A 12 -Month, Open-label, Multi-center Pilot Study to Explore the Health Outcomes of FTY720 in RRMS Patients Who Have Previously Been Treated With Other Disease Modifying Therapies (DMT)- Fine | Multiple Sclerosis;Relapsing-Remitting | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 42 | Phase 4 | Turkey |
| 793 | EUCTR2011-001437-16-DE (EUCTR) | 19/09/2012 | 09/02/2012 | A 3 year study to determine if optical coherence tomography can be used to measure disease progression in patients with multiple sclerosis | A 3-year, multi-center study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis - | multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Extavia INN or Proposed INN: Interferon beta-1b Other descriptive name: INTERFERON BETA-1B Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Czech Republic;United Kingdom;Canada;Denmark;Spain;United States;Poland | |||
| 794 | EUCTR2012-000635-68-IE (EUCTR) | 19/09/2012 | 09/02/2012 | An initial, short-duration study of vitamin D versus an inactive therapy on the ability of the human immune system to counteract the effects of Multiple Sclerosis on the brain and the effects of vitamin D on the immune system in healthy individuals. | Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome or early multiple sclerosis and healthy control participants. An exploratory randomised double blind placebo controlled study - N/A | Multiple Sclerosis MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Product Name: N/A Product Code: N/A | University College Dublin | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Ireland | |||
| 795 | NCT01628393 (ClinicalTrials.gov) | September 18, 2012 | 22/6/2012 | Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients (Radiance Study) | A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients | Relapsing Multiple Sclerosis | Drug: RPC1063;Drug: placebo | Celgene | NULL | Completed | 18 Years | 55 Years | All | 258 | Phase 2;Phase 3 | United States;Belgium;Bulgaria;Georgia;Greece;Hungary;Italy;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 796 | EUCTR2012-000957-30-CZ (EUCTR) | 11/09/2012 | 18/06/2012 | BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple Sclerosis | BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis | Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS) MedDRA version: 17.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum Toxin Type A | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 184 | Portugal;France;United States;Czech Republic;Canada;Poland;Belgium;Russian Federation;United Kingdom | |||
| 797 | NCT04371575 (ClinicalTrials.gov) | September 1, 2012 | 29/4/2020 | Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - a Prospective Study in 60 Patients | Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - Clinical Characteristics, Neuroanatomical Abnormalities and Treatment Efficacy | Trigeminal Neuralgia;Multiple Sclerosis;Pain, Neuropathic | Drug: Carbamazepine | Stine Maarbjerg, MD PhD | NULL | Completed | N/A | N/A | All | 60 | NULL | |
| 798 | NCT02463318 (ClinicalTrials.gov) | September 2012 | 2/6/2015 | The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects | Multiple Sclerosis;Oxidative Stress | Drug: Melatonin;Other: Hydrogen peroxide | Tehran University of Medical Sciences | NULL | Completed | 20 Years | 40 Years | Female | 34 | N/A | Iran, Islamic Republic of | |
| 799 | NCT01706055 (ClinicalTrials.gov) | September 2012 | 7/9/2012 | Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE) | Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon® | Multiple Sclerosis | Biological: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | All | 629 | N/A | Poland |
| 800 | NCT01701856 (ClinicalTrials.gov) | September 2012 | 18/9/2012 | Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis | Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis: A Swiss Multicenter Study Prospective, Controlled, Single-arm, Open-label, Multi-centre, Phase IV Study | Relapsing-remitting Multiple Sclerosis | Drug: Interferon beta-1b | Claudio Gobbi | Bayer | Terminated | 18 Years | 70 Years | Both | 5 | Phase 4 | Switzerland |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 801 | NCT01667497 (ClinicalTrials.gov) | September 2012 | 13/8/2012 | Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients? | Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients? A Cross Over Study | Cognitive Fatigue | Drug: Fampridine SR;Drug: Placebo | London Health Sciences Centre | NULL | Completed | 18 Years | 64 Years | Both | 60 | Phase 2;Phase 3 | Canada |
| 802 | NCT01667484 (ClinicalTrials.gov) | September 2012 | 13/8/2012 | Adderall XR and Processing Speed in Multiple Sclerosis (MS) | Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients? | Impaired Processing Speed;Cognitive Impairment;Multiple Sclerosis | Drug: Adderall XR 5mg;Drug: Adderall XR 10 mg;Drug: Placebo | London Health Sciences Centre | NULL | Completed | 18 Years | 59 Years | Both | 70 | Phase 2;Phase 3 | Canada |
| 803 | NCT02442570 (ClinicalTrials.gov) | September 2012 | 1/5/2015 | A Study to Evaluate Safety and Efficacy of DC-TAB in Multiple Sclerosis | A Phase IIa, Randomized, Double-blind, Placebo-controlled, Exploratory, Dose-ranging Study to Evaluate the Safety, Effectiveness and Pharmacokinetics of Three Courses of DC-TAB Treatment in Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: recombinant human alpha B-crystallin;Other: Placebo comparator | Delta Crystallon BV | NULL | Completed | 18 Years | 55 Years | Both | 32 | Phase 2 | Bulgaria |
| 804 | EUCTR2012-000957-30-BE (EUCTR) | 28/08/2012 | 01/06/2012 | BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple Sclerosis | BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis | Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum Toxin Type A | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 184 | France;United States;Portugal;Czech Republic;Canada;Poland;Belgium;Russian Federation;United Kingdom | |||
| 805 | NCT01705236 (ClinicalTrials.gov) | August 20, 2012 | 13/8/2012 | A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya® | A 3-year Multi-center Study to Describe the Long Term Changes of Optical Coherence Tomography (OCT) Parameters in Patients Under Treatment With Gilenya® | Relapsing Remitting Multiple Sclerosis RRMS | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 87 | Phase 4 | Germany;Switzerland |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 806 | EUCTR2009-017978-21-PL (EUCTR) | 17/08/2012 | 06/03/2012 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2175 | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | |||
| 807 | NCT01633112 (ClinicalTrials.gov) | August 9, 2012 | 29/6/2012 | MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone | A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis (RRMS) | Drug: fingolimod;Drug: glatiramer acetate | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 1064 | Phase 3 | United States;Argentina;Brazil;Canada;Chile;Mexico;Puerto Rico |
| 808 | EUCTR2012-000674-31-DE (EUCTR) | 01/08/2012 | 27/04/2012 | A 3-year, multi-center study to describe the long term changes of optical coherence tomography (OCT) parameters in patients under treatment with Gilenya® | A 3-year, multi-center study to describe the long term changes of optical coherence tomography (OCT) parameters in patients under treatment with Gilenya® | RNFLT in Patients with relapsing remitting Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: Fingolimod Hydrochloride | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Germany;Switzerland | ||
| 809 | EUCTR2009-017978-21-PT (EUCTR) | 06/07/2012 | 11/08/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2175 | Phase 3 | Serbia;United States;United Arab Emirates;Portugal;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 810 | NCT01639300 (ClinicalTrials.gov) | July 2012 | 10/7/2012 | Safety Study of GNbAC1 in Multiple Sclerosis Patients | Randomised Placebo-Controlled Single Blind Study to Investigate Single Ascending Doses of GNbAC1 in Multiple Sclerosis Patients Followed by Open-label Extension With Repeated Doses of GNbAC1 | Multiple Sclerosis | Biological: GNbAC1;Biological: GNbAC1 placebo | GeNeuro Innovation SAS | NULL | Completed | 18 Years | 65 Years | All | 10 | Phase 2 | Switzerland |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 811 | EUCTR2012-000653-32-DE (EUCTR) | 27/06/2012 | 12/04/2012 | A study to explore heart function during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis | A 1-week, open-label, multi-center study to explore conduction abnormalities during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis (START) - START | Conduction abnormalities in patients with relapsing-remitting multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: Fingolimod Hydrochloride | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | |||
| 812 | EUCTR2012-000518-13-DK (EUCTR) | 21/06/2012 | 21/06/2012 | Own mesenchymal stem cells for multiple sclerosis patients | Immunomodulating and neuroprotective properties of autologous multipotent mesenchymal stem cells in patients with multiple sclerosis - A randomised placebo-controlled double-blinded phase II study - COMSCIMS | Multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mesenchymal stem/stromal cells Product Name: Mesenchymal stem cells (MSCs) | Prof. Per Soelberg Sørensen | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 813 | NCT01600716 (ClinicalTrials.gov) | June 13, 2012 | 15/5/2012 | Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS) | Urinary Incontinence;Multiple Sclerosis;Neurogenic Bladder | Biological: OnabotulinumtoxinA;Drug: Placebo (Normal Saline) | Allergan | NULL | Completed | 18 Years | N/A | All | 144 | Phase 3 | United States;Belgium;Canada;Czechia;France;Poland;Portugal;Russian Federation;Czech Republic | |
| 814 | EUCTR2010-023172-12-LT (EUCTR) | 12/06/2012 | 13/04/2012 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | |||
| 815 | NCT01623596 (ClinicalTrials.gov) | June 8, 2012 | 18/6/2012 | Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis. | A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults With Relapsing Remitting Multiple Sclerosis (PREFERMS) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Disease Modifying therapy | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 881 | Phase 4 | United States;Puerto Rico |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 816 | EUCTR2011-005550-57-GR (EUCTR) | 05/06/2012 | 09/05/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Montenegro;Bulgaria;Latvia;Lithuania;Albania;Russian Federation;Serbia;Ukraine;Belarus;Mexico;Georgia;Romania;Estonia;Bosnia and Herzegovina;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Moldova, Republic of | |||
| 817 | JPRN-jRCTs031180152 | 04/06/2012 | 25/02/2019 | Tocilizumab in patients with neuromyelitis optica | The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter study - Tocilizumab in patients with neuromyelitis optica | Neuromyelitis optica;D009471 | Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months. | Yamamura Takashi | NULL | Complete | >= 20age old | <= 65age old | Both | 20 | N/A | Japan |
| 818 | EUCTR2012-000287-17-IT (EUCTR) | 21/05/2012 | 18/06/2012 | functional MRI study to evaluate improvement of hand performance after combined motor exercise and aminopiridine assumption | PROMOTION OF FUNCTIONAL RESTORATION THROUGH PHARMACOLOGICAL MODULATION OF BRAIN PLASTICITY WITH AMINOPYRIDINE IN PATIENTS WITH MULTIPLE SCLEROSIS STUDIED BY FUNCTIONAL MRI | Patients with MS, without relevant medical conditions, with right upper limb impairment assessed by a hand dexterity test will be included.Patients will be in a non-active phase of the disease and under a stable pharmacological treatment.They will not be included if they have received physiotherapy in the previous few months. Healthy volunteers will be recruited if they have no relevant medical condition and no contraindication to perform a MRI scan. MedDRA version: 14.1;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: FAMPYRA INN or Proposed INN: FAMPRIDINE | FONDAZIONE SANTA LUCIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 819 | EUCTR2011-005550-57-EE (EUCTR) | 21/05/2012 | 14/02/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Albania;Bulgaria;Latvia;Germany;Moldova, Republic of;Bosnia and Herzegovina | |||
| 820 | EUCTR2011-004475-36-BG (EUCTR) | 19/05/2012 | 10/04/2012 | A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosis | A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DC-TAB Product Code: DC-TAB Other descriptive name: recombinant human alpha B-crystallin | Delta Crystallon B.V. | NULL | Not Recruiting | Female: yes Male: yes | Phase 2a | Bulgaria | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 821 | EUCTR2011-005550-57-LV (EUCTR) | 15/05/2012 | 09/02/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Albania;Bulgaria;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | |||
| 822 | EUCTR2011-005550-57-BG (EUCTR) | 14/05/2012 | 07/03/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Germany;Moldova, Republic of;Bosnia and Herzegovina;Latvia;Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Bulgaria;Albania | |||
| 823 | JPRN-UMIN000007866 | 2012/05/01 | 01/05/2012 | The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter Study | neuromyelitis optica | Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 years. | Department of Immunology, National Institute of Neuroscience, NCNP | Department of Neurology, Kinki University Faculty of Mediceine | Complete: follow-up continuing | 20years-old | 65years-old | Male and Female | 15 | Not applicable | Japan | |
| 824 | NCT02142205 (ClinicalTrials.gov) | May 2012 | 16/5/2014 | Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS) | A Prospective, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Efficacy in RUSsian RRMS Patients on One Year Treatment With Natalizumab (TYSabri®). | Relapsing-Remitting Multiple Sclerosis | Biological: BG00002 | Biogen Idec | Biogen Idec International GmbH | Completed | 18 Years | 60 Years | Both | 100 | Phase 4 | Russian Federation |
| 825 | NCT01491100 (ClinicalTrials.gov) | April 30, 2012 | 12/12/2011 | Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis | Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon® | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 12 Years | 70 Years | All | 1085 | Albania;Algeria;Argentina;Belgium;Czechia;Egypt;France;Germany;Greece;Hungary;Israel;Kazakhstan;Netherlands;Portugal;Saudi Arabia;Tunisia;Turkey;Bosnia and Herzegovina;Czech Republic;Jordan;Lebanon;Mexico;Poland;Syrian Arab Republic | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 826 | NCT01585298 (ClinicalTrials.gov) | April 29, 2012 | 23/4/2012 | STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START) | A 1-week, Open-label, Multi-center Study to Explore Conduction Abnormalities During First Dose Administration of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: FTY720 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 6998 | Phase 4 | Germany |
| 827 | EUCTR2011-002178-22-GB (EUCTR) | 27/04/2012 | 29/03/2012 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 828 | EUCTR2011-005606-30-GB (EUCTR) | 25/04/2012 | 02/04/2012 | Preventing patients with multiple sclerosis from developing side effects following treatment with alemtuzumab (Campath-1H). | Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY - CAM-THY | This trial will test the efficacy of Kepivance in the prevention of new autoimmune diseases in patients who have multiple sclerosis (MS)who are being treated with alemtuzumab. MedDRA version: 14.1;Level: PT;Classification code 10058948;Term: Nephritis autoimmune;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1;Classification code 10049046;Term: Autoimmune thyroiditis;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.1;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Level: LLT;Classification code 10068004;Term: Autoimmune hyperthyroidism;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Cambridge University Hospitals NHS Foundation Trust and University of Cambridge | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 2 | United Kingdom | |||
| 829 | EUCTR2011-002683-24-BG (EUCTR) | 17/04/2012 | 10/01/2012 | A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis | A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis | relapsing forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: NU100 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Betaferon Product Name: Betaferon INN or Proposed INN: n/a Other descriptive name: INTERFERON BETA-1B | Nuron Biotech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Belarus;Hungary;Spain;Poland;Ukraine;Lebanon;Croatia;Georgia;Russian Federation;Bulgaria;Italy | ||
| 830 | EUCTR2010-020337-99-NL (EUCTR) | 13/04/2012 | 19/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Netherlands;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 831 | EUCTR2011-005550-57-PL (EUCTR) | 04/04/2012 | 09/03/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Hungary;Germany;Montenegro;Bulgaria;Latvia;Lithuania;Albania;Russian Federation;Czech Republic;Ukraine;Serbia;Belarus;Mexico;Georgia;Romania;Estonia;Bosnia and Herzegovina;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Moldova, Republic of | |||
| 832 | NCT01627938 (ClinicalTrials.gov) | April 2012 | 30/5/2012 | Study to Evaluate the Reduction of Cardiac Problems in Multiple Sclerosis Patients With Mitoxantrone and Dexrazoxane in Combination | A Phase II Proof of Concept Study Evaluating the Reduction of Mitoxantrone-induced Cardiotoxicity and Neurological Outcome in the Combined Use of Mitoxantrone and Dexrazoxane (Cardioxane®) in Multiple Sclerosis (MSCardioPro) | Multiple Sclerosis | Drug: Dexrazoxane (DRZ) plus Mitoxantrone (MX);Drug: Placebo plus Mitoxantrone (MX) | PD Dr. Andrew Chan | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 50 | Phase 2 | Germany |
| 833 | EUCTR2010-020515-37-NO (EUCTR) | 22/03/2012 | 15/02/2011 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 834 | EUCTR2011-002178-22-PL (EUCTR) | 20/03/2012 | 25/11/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 15.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 835 | EUCTR2011-002683-24-HU (EUCTR) | 02/03/2012 | 15/12/2011 | A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis | A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis | relapsing forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: NU100 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Betaferon Product Name: Betaferon INN or Proposed INN: n/a Other descriptive name: INTERFERON BETA-1B | Nuron Biotech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | Belarus;Hungary;Spain;Poland;Ukraine;Lebanon;Croatia;Bulgaria;Georgia;Russian Federation;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 836 | NCT01576354 (ClinicalTrials.gov) | March 2012 | 22/3/2012 | Characterization of the Effects of Prolonged-release Fampridine on Ambulatory Function in Patients With Multiple Sclerosis | A Phase IIb, Double-blind, Randomized, Mono-center, Placebo-controlled Study With Crossover Design Characterizing the Effects of Prolonged-release Fampridine Treatment on Ambulatory Function in Patients With Multiple Sclerosis Using Detailed Gait Analysis Based on Kinematic and Kinetic Parameters | Multiple Sclerosis | Drug: Prolonged-release Fampridine;Drug: Placebo | University of Zurich | NULL | Active, not recruiting | 18 Years | 65 Years | Both | 70 | Phase 2 | Switzerland |
| 837 | NCT01591551 (ClinicalTrials.gov) | March 2012 | 22/4/2012 | NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness | NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab (Tysabri) | Cornerstone Health Care, PA | Biogen Idec | Completed | 18 Years | 65 Years | Both | 37 | Phase 4 | United States |
| 838 | NCT01436838 (ClinicalTrials.gov) | March 2012 | 19/9/2011 | China Betaferon Adherence, Coping and Nurse Support Study | Prospective Study of Betaferon in Adherence, Coping and Nurse Support in Patients of Chinese Origin With Multiple Sclerosis | Multiple Sclerosis, Chronic Progressive | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 75 Years | Both | 110 | N/A | China |
| 839 | EUCTR2011-006151-10-DK (EUCTR) | 15/02/2012 | 15/02/2012 | FAME - a study of the effect of Fampyra on muscle strength in the lower extremities, walking capacity, coordination in the upper extremitties and cognition in multiple sclerosis patients. | FAME - Fampyra outcome measures study: a study of responsiveness of different outcome measures to Fampyra treatment. - FAME | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampyra INN or Proposed INN: FAMPRIDINE | Sønderjylland Hospital, department of neurology | NULL | Not Recruiting | Female: yes Male: yes | Denmark | ||||
| 840 | EUCTR2011-002683-24-IT (EUCTR) | 14/02/2012 | 23/12/2011 | A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis | A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis | relapsing forms of multiple sclerosis MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: NU100 Trade Name: Betaferon Other descriptive name: INTERFERON BETA-1B | NURON BIOTECH INC. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Belarus;Hungary;Spain;Bulgaria;Russian Federation;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 841 | EUCTR2011-002178-22-CZ (EUCTR) | 08/02/2012 | 02/11/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 842 | NCT01485003 (ClinicalTrials.gov) | February 7, 2012 | 1/12/2011 | Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants | A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients | Relapsing-Remitting Multiple Sclerosis | Biological: natalizumab | Biogen | NULL | Completed | 18 Years | 65 Years | All | 231 | United States | |
| 843 | EUCTR2010-021219-17-SK (EUCTR) | 01/02/2012 | 06/07/2011 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Tunisia;Germany;Bosnia and Herzegovina | |||
| 844 | NCT01516554 (ClinicalTrials.gov) | February 2012 | 19/1/2012 | Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients | A Randomized, Controlled Crossover Trial Evaluating Oral Testosterone in the Treatment of Fatigue in Male Multiple Sclerosis Patients | Multiple Sclerosis;Fatigue | Drug: Testosterone undecanoate;Drug: placebo | Health Sciences Centre, Winnipeg, Manitoba | University of Manitoba;Consortium of Multiple Sclerosis Centers;Manitoba Medical Service Foundation | Terminated | 18 Years | 65 Years | Male | 3 | Phase 2 | Canada |
| 845 | NCT01433250 (ClinicalTrials.gov) | February 2012 | 26/8/2011 | A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis | An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: AIN457 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 39 | Phase 2 | Czech Republic;Russian Federation;Ukraine |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 846 | NCT01497262 (ClinicalTrials.gov) | February 2012 | 5/12/2011 | Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis | A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 162 | Phase 3 | Argentina;Brazil;Colombia;Jordan;Malaysia;Mexico;Panama;Peru;Costa Rica |
| 847 | NCT01569451 (ClinicalTrials.gov) | February 2012 | 30/3/2012 | Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate | A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Rituximab;Drug: Glatiramer Acetate;Other: Placebo | University of Colorado, Denver | Rocky Mountain MS Research Group, LLC | Completed | 18 Years | 55 Years | All | 53 | Phase 2 | United States |
| 848 | EUCTR2011-002683-24-ES (EUCTR) | 30/01/2012 | 14/11/2011 | A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis | A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis | Relapsing forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: NU100 Trade Name: Betaferon Product Name: Betaferon Other descriptive name: INTERFERON BETA-1B | Nuron Biotech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | Hungary;Russian Federation;Ukraine;Belarus;Georgia;Bulgaria;Spain;Italy;Croatia;Poland | ||
| 849 | EUCTR2009-012500-11-SI (EUCTR) | 27/01/2012 | 10/01/2012 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab wih Greek suffix Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Germany;France;Ireland;Australia;Sweden;Brazil;Czech Republic;Serbia;Canada;United States;Greece;Poland;Hungary;Switzerland;Italy;Israel;Finland;India;United Kingdom;Russian Federation;Ukraine;Mexico;Argentina;Slovenia;Denmark;Romania;Spain | |||
| 850 | EUCTR2011-000888-27-DE (EUCTR) | 24/01/2012 | 19/08/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 851 | EUCTR2009-017978-21-GR (EUCTR) | 17/01/2012 | 08/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Saudi Arabia;Taiwan;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 852 | EUCTR2011-001442-15-SE (EUCTR) | 11/01/2012 | 17/11/2011 | A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimod | A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) | relapsing remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Greece;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Australia;Denmark;Germany;Norway;Sweden | |||
| 853 | EUCTR2011-001629-25-CZ (EUCTR) | 10/01/2012 | 11/10/2011 | A clinical extension study to evaluate the safety, tolerability and efficacy of AIN457 in multiple sclerosis patients with relapses | An open label extension study to evaluate the safety, tolerability and efficacy of AIN457 in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: rhumAb to IL-17A igG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Czech Republic;Ukraine;Russian Federation | |||
| 854 | EUCTR2011-000888-27-GR (EUCTR) | 09/01/2012 | 13/12/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 855 | EUCTR2010-020328-23-PT (EUCTR) | 06/01/2012 | 17/11/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA - Geneva, an affiliate of Merck KGaA | ,NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 856 | EUCTR2010-023023-19-DE (EUCTR) | 04/01/2012 | 18/11/2011 | Studyto compare the efficacy and safety of fingolimod and interferon-beta-1b in patients with mutliple sclerosis | A 18-month, open-label, rater-blinded, randomized, multicenter, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod in comparison to interferon beta 1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy | treating of cognitive symptoms in relapsing-remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Extavia Other descriptive name: INTERFERON BETA-1B Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Extavia Product Name: Extavia Product Code: NVF233 Other descriptive name: INTERFERON BETA-1B | Novartis Farma S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | Germany;Italy | ||||
| 857 | NCT01601119 (ClinicalTrials.gov) | January 2012 | 15/5/2012 | Impact of Disease Modifying Therapies (DMTs) and Associated Support Services in Relapsing Multiple Sclerosis (RMS) Patients | The Impact of Disease Modifying Therapies (DMTs) and Associated Support Services on Patient Reported Experience Measures (PREMs) and Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients | Relapsing Multiple Sclerosis | Drug: Rebif;Other: Other: Disease modifying therapies (DMT) | Merck KGaA | Merck Serono Limited, UK | Completed | 18 Years | N/A | Both | 545 | N/A | United Kingdom |
| 858 | NCT01517282 (ClinicalTrials.gov) | January 2012 | 10/1/2012 | Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety and Pharmacokinetics of MOR103, a Human Antibody to GM-CSF, in Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: MOR103;Other: Placebo | MorphoSys AG | NULL | Completed | 18 Years | 60 Years | All | 32 | Phase 1;Phase 2 | Germany;Poland;United Kingdom |
| 859 | NCT01534182 (ClinicalTrials.gov) | January 2012 | 8/2/2012 | Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC) | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Interferon beta - 1a (IFN);Drug: Glatiramer acetate (GA) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 298 | Phase 4 | Russian Federation |
| 860 | NCT02280876 (ClinicalTrials.gov) | January 2012 | 20/10/2014 | Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS) | Randomized, Comparative, Double Blind Controlled Phase II Clinical Trial, to Evaluate the Efficacy of ApE in Patients With Multiple Sclerosis (MS). | Multiple Sclerosis, Relapsing-Remitting | Drug: 1 - Andrographis paniculata p/st extract;Drug: 2 - Excipients | Universidad Austral de Chile | Comisión Nacional de Investigación Científica y Tecnológica;University of Chile | Completed | 18 Years | 55 Years | Both | 30 | Phase 1;Phase 2 | Chile |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 861 | NCT01964547 (ClinicalTrials.gov) | January 2012 | 15/10/2013 | A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients | A Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study of the Effect of Long-term Treatment With Sativex on Cognitive Function and Mood of Patients With Spasticity Due to Multiple Sclerosis | Multiple Sclerosis;Spasticity | Drug: Sativex;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 121 | Phase 4 | Czech Republic |
| 862 | EUCTR2011-002178-22-ES (EUCTR) | 26/12/2011 | 31/10/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HIDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HiDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HIDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Poland;Spain;Bulgaria;United Kingdom | ||
| 863 | NCT01498887 (ClinicalTrials.gov) | December 24, 2011 | 19/12/2011 | Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy | A Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis. | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod (FTY720) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 50 Years | All | 347 | Phase 4 | Australia;Spain |
| 864 | NCT02967380 (ClinicalTrials.gov) | December 14, 2011 | 13/9/2015 | Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases | Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions | Adult Anaplastic (Malignant) Meningioma;Adult Anaplastic Astrocytoma;Adult Anaplastic Ependymoma;Adult Anaplastic Oligodendroglioma;Adult Brain Stem Glioma;Adult Choroid Plexus Neoplasm;Adult Diffuse Astrocytoma;Adult Ependymoblastoma;Adult Ependymoma;Adult Giant Cell Glioblastoma;Adult Glioblastoma;Adult Gliosarcoma;Adult Grade II Meningioma;Adult Medulloblastoma;Adult Mixed Glioma;Adult Oligodendroglioma;Adult Papillary Meningioma;Adult Pineal Gland Astrocytoma;Adult Pineoblastoma;Adult Primary Melanocytic Lesion of Meninges;Adult Supratentorial Primitive Neuroectodermal Tumor;Malignant Adult Intracranial Hemangiopericytoma;Metastatic Malignant Neoplasm in the Brain;Multiple Sclerosis;Recurrent Adult Brain Neoplasm | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging;Drug: Gadobenate Dimeglumine;Drug: Gadobutrol;Radiation: Gadopentetate Dimeglumine | University of Southern California | National Cancer Institute (NCI) | Terminated | 18 Years | N/A | All | 14 | N/A | United States |
| 865 | EUCTR2011-003570-89-NL (EUCTR) | 02/12/2011 | 07/11/2011 | The effect of interferon beta-1a treatment on adaptability of the brain in patients with MS | The effect of interferon beta-1a treatment on functional adaptation in Multiple Sclerosis (MS) - interferon beta-1a and functional adaptation | Multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10004504;Term: Beta interferon therapy;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: interferon beta-1a | VU University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 866 | EUCTR2010-020315-36-BG (EUCTR) | 28/11/2011 | 19/08/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 867 | EUCTR2010-020328-23-AT (EUCTR) | 23/11/2011 | 28/10/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA - Geneva, an affiliate of Merck KGaA | ,NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 868 | EUCTR2011-001442-15-HU (EUCTR) | 22/11/2011 | 12/10/2011 | A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimod | A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) | relapsing remitting multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 142 | Greece;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Australia;Denmark;Germany;Norway;Sweden | |||
| 869 | EUCTR2011-000888-27-RO (EUCTR) | 18/11/2011 | 09/10/2012 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 870 | EUCTR2011-001442-15-FI (EUCTR) | 16/11/2011 | 15/09/2011 | A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimod | A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) | relapsing remitting multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 142 | Greece;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Australia;Denmark;Germany;Norway;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 871 | EUCTR2010-020315-36-BE (EUCTR) | 14/11/2011 | 30/06/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | |||
| 872 | EUCTR2011-002969-38-DE (EUCTR) | 08/11/2011 | 30/09/2011 | A 6-month, multicenter, randomized, controlled parallel group study to evaluate the effect of physical training on fatigue in patients with relapsing-remitting multiple sclerosis treated with fingolimod (Gilenya®), followed by a 6 month optional extension phase | A 6-month, multicenter, randomized, controlled parallel group study to evaluate the effect of physical training on fatigue in patients with relapsing-remitting multiple sclerosis treated with fingolimod (Gilenya®), followed by a 6 month optional extension phase - | Fatigue in Patients with relapsing remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: Fingolimod Hydrochloride | Novartis Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase A | Germany | |||
| 873 | EUCTR2011-001442-15-IT (EUCTR) | 04/11/2011 | 27/02/2012 | A study to evaluate disease control and safety in patients with RRMS (relapsing remitting multiple sclerosis) switching from natalizumab to fingolimod | A 32-week, patient- and rater-blinded, randomized, multicenter, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) | relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: GYLENIA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Czech Republic;Greece;Finland;Spain;Austria;Australia;Israel;Germany;United Kingdom;Italy;Sweden | |||
| 874 | EUCTR2010-020315-36-IE (EUCTR) | 04/11/2011 | 08/09/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 875 | NCT01436643 (ClinicalTrials.gov) | November 2011 | 16/9/2011 | Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression | A 21-week, Multicenter, Open Label Study to Evaluate the Safety and Tolerability Profile of the Combination of a SSRI or SNRI Antidepressive Therapy With Oral Fingolimod in the Treatment of RRMS Patients With Mild to Moderate Depression | Depression;Relapsing-remitting Multiple Sclerosis | Drug: Venlafaxine;Drug: Fluoxetine;Drug: Citalopram;Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 54 | Phase 4 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 876 | EUCTR2010-021219-17-DE (EUCTR) | 31/10/2011 | 05/07/2011 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis - Not applicable | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Germany;Tunisia;Bosnia and Herzegovina | |||
| 877 | EUCTR2011-003484-30-ES (EUCTR) | 26/10/2011 | 12/04/2012 | A multi-centre, open-label, non-randomised, parallel group clinical trial to assess the efficacy of fingolimod in naïve patients versus fingolimod in patients previously treated with interferons or glatiramer acetate, based on the presence of relapses in patients with relapsing-remitting multiple sclerosis. | A multi-centre, open-label, non-randomised, parallel group clinical trial to assess the efficacy of fingolimod in naïve patients versus fingolimod in patients previously treated with interferons or glatiramer acetate, based on the presence of relapses in patients with relapsing-remitting multiple sclerosis. - Earlims | Multiple Sclerosis relapsing-remitting course;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya INN or Proposed INN: Fingolimod | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 432 | Phase 3 | Spain;Australia | ||
| 878 | EUCTR2010-020337-99-PL (EUCTR) | 25/10/2011 | 13/09/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Poland;Belgium;Bulgaria;Germany;New Zealand | |||
| 879 | EUCTR2011-000888-27-GB (EUCTR) | 24/10/2011 | 01/08/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 880 | EUCTR2010-020337-99-GB (EUCTR) | 20/10/2011 | 05/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 881 | EUCTR2010-020315-36-GB (EUCTR) | 20/10/2011 | 16/08/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 882 | EUCTR2010-020315-36-SK (EUCTR) | 18/10/2011 | 28/06/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 883 | EUCTR2010-020315-36-ES (EUCTR) | 18/10/2011 | 21/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Colombia;Turkey;Ireland;Italy;Sweden;Brazil;United Kingdom;Russian Federation;Ukraine;Canada;Peru;Belarus;Belgium;Mexico;Argentina;Spain;Bosnia and Herzegovina;United States;Croatia | |||
| 884 | EUCTR2011-000888-27-IT (EUCTR) | 13/10/2011 | 24/01/2012 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallelgroup, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: glatiramer acetate | SYNTHON BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Estonia;Czech Republic;Greece;Ukraine;Romania;Croatia;Bulgaria;Russian Federation;Germany;United Kingdom;Italy | |||
| 885 | EUCTR2011-001442-15-CZ (EUCTR) | 13/10/2011 | 09/08/2011 | A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) | A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) - TOFINGO | relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 142 | Greece;Finland;Spain;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 886 | EUCTR2010-020315-36-FR (EUCTR) | 07/10/2011 | 02/09/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 887 | EUCTR2010-020315-36-IT (EUCTR) | 05/10/2011 | 27/12/2011 | A study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis. | A Randomized, Double-Blind, Double Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis. - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: OCRELIZUMAB Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | ROCHE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 469 | Colombia;Turkey;Ireland;Italy;Sweden;Brazil;United Kingdom;Russian Federation;Canada;Ukraine;Belarus;Peru;Belgium;Argentina;Mexico;Spain;Bosnia and Herzegovina;United States;Croatia | |||
| 888 | NCT01464905 (ClinicalTrials.gov) | October 2011 | 31/10/2011 | Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | A Phase 3, Multicenter, Double-blind,Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of NU100 in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Biological: NU100;Biological: Placebo;Biological: rhIFN beta-1b | Nuron Biotech Inc. | NULL | Active, not recruiting | 18 Years | 60 Years | Both | 500 | Phase 3 | Belarus;Bulgaria;Croatia;Georgia;Hungary;Italy;Lebanon;Poland;Russian Federation;Serbia;Spain;Ukraine;India |
| 889 | NCT01453868 (ClinicalTrials.gov) | October 2011 | 13/10/2011 | The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis | The Effects of Neuromuscular Training on Balance in Patients With Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Other: Non Impact Aerobics;Other: Passive : lecture series | Nelson Mandela Metropolitan University | NULL | Recruiting | 20 Years | 60 Years | Both | 60 | Phase 0 | United States |
| 890 | EUCTR2010-020315-36-DE (EUCTR) | 22/09/2011 | 08/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 891 | EUCTR2011-000888-27-CZ (EUCTR) | 21/09/2011 | 17/06/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 892 | EUCTR2011-001442-15-AT (EUCTR) | 21/09/2011 | 27/07/2011 | A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimod | A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) | relapsing remitting multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Greece;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Australia;Denmark;Norway;Germany;Sweden | |||
| 893 | EUCTR2011-000888-27-EE (EUCTR) | 21/09/2011 | 01/09/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 894 | EUCTR2009-017978-21-DK (EUCTR) | 21/09/2011 | 12/09/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 895 | EUCTR2010-020337-99-ES (EUCTR) | 21/09/2011 | 20/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Germany;Bulgaria;Austria;South Africa;Brazil;Australia;Tunisia;Czech Republic;Serbia;New Zealand;Peru;Belgium;United States;Poland;Portugal;Hungary;Switzerland;Chile;Italy;Morocco;Latvia;Lithuania;Israel;Finland;Russian Federation;United Kingdom;Ukraine;Mexico;Argentina;Estonia;Spain | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 896 | NCT01412333 (ClinicalTrials.gov) | September 20, 2011 | 8/8/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placebo | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 835 | Phase 3 | United States;Argentina;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;France;Germany;Ireland;Italy;Mexico;Norway;Poland;Russian Federation;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic;Morocco |
| 897 | EUCTR2010-020337-99-IT (EUCTR) | 19/09/2011 | 29/03/2012 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a inPatients With Relapsing Multiple Sclerosis. | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study ToEvaluate The Efficacy And Safety Of Ocrelizumab In Comparison ToInterferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis. - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: OCRELIZUMAB Other descriptive name: NA Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: NA Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: NA Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: NA | ROCHE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Germany;Bulgaria;Austria;South Africa;Brazil;Australia;Tunisia;Czech Republic;New Zealand;Peru;Belgium;United States;Poland;Portugal;Hungary;Switzerland;Chile;Italy;Morocco;Latvia;Lithuania;Israel;Finland;Russian Federation;United Kingdom;Ukraine;Mexico;Argentina;Estonia;Spain | |||
| 898 | NCT01435993 (ClinicalTrials.gov) | September 8, 2011 | 25/8/2011 | Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis | A Randomized, Single Blind, Placebo-controlled, Single Ascending Dose/Repeat Dose Cohort Study to Assess Safety, Tolerability, Pharmacokinetics and Immunogenicity of GSK1223249 in Patients With Relapsing Forms of Multiple Sclerosis. | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK1223249;Other: Saline placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | 60 Years | All | 3 | Phase 1 | Italy;Norway;Germany |
| 899 | EUCTR2010-020337-99-DE (EUCTR) | 05/09/2011 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 900 | EUCTR2011-001442-15-GR (EUCTR) | 02/09/2011 | 15/07/2011 | A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimod | A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) | relapsing remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Greece;Finland;Spain;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 901 | NCT01324232 (ClinicalTrials.gov) | September 2011 | 23/3/2011 | Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients With Multiple Sclerosis | Central Neuropathic Pain;Multiple Sclerosis | Drug: AVP-923;Drug: Placebo | Avanir Pharmaceuticals | NULL | Completed | 18 Years | 85 Years | All | 200 | Phase 2 | United States;Argentina;Czechia;Poland;Spain;Czech Republic;Germany;United Kingdom |
| 902 | NCT01499667 (ClinicalTrials.gov) | September 2011 | 18/8/2011 | Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod | A 32-week, Patient- and Rater-blinded, Randomized, Multi-center, Parallel-group Study to Evaluate Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis Transferred From Previous Treatment With Natalizumab to Fingolimod (FTY720) | Relapsing Remitting Multiple Sclerosis (RRMS) | Drug: Fingolimod;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 142 | Phase 3 | Australia;Austria;Czech Republic;Finland;Germany;Greece;Hungary;Israel;Italy;Spain;Switzerland |
| 903 | NCT01403376 (ClinicalTrials.gov) | September 2011 | 14/7/2011 | Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide | Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide Treatment and Using a Population of Patients With Multiple Sclerosis as a Reference | Multiple Sclerosis | Drug: teriflunomide;Drug: Interferon-ß-1;Biological: Influenza vaccine | Sanofi | NULL | Completed | 18 Years | 59 Years | All | 128 | Phase 2 | Austria;Canada;Germany;Russian Federation;Ukraine |
| 904 | EUCTR2010-020315-36-SE (EUCTR) | 31/08/2011 | 05/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 905 | NCT01247324 (ClinicalTrials.gov) | August 31, 2011 | 23/11/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placebo | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 821 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Chile;Czechia;Estonia;Finland;France;Germany;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Ukraine;United Kingdom;Czech Republic;Morocco;New Zealand |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 906 | EUCTR2011-001442-15-DE (EUCTR) | 26/08/2011 | 26/05/2011 | A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimod | A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) | relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 142 | Greece;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Australia;Denmark;Germany;Norway;Sweden | |||
| 907 | EUCTR2011-000888-27-BG (EUCTR) | 18/08/2011 | 11/07/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 908 | NCT01442194 (ClinicalTrials.gov) | August 1, 2011 | 21/8/2011 | Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies | Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy | Multiple Sclerosis | Drug: other disease-modifying therapy;Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Recruiting | N/A | N/A | All | 3620 | United States;Argentina;Australia;Canada;Chile;Mexico;Puerto Rico | |
| 909 | NCT01433497 (ClinicalTrials.gov) | August 2011 | 12/9/2011 | Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis | A 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Relapse Free | Drug: Masitinib;Drug: Placebo | AB Science | NULL | Completed | 18 Years | 75 Years | All | 656 | Phase 3 | Bulgaria;France;Germany;Greece;Poland;Romania;Spain;United States |
| 910 | NCT01420055 (ClinicalTrials.gov) | August 2011 | 17/8/2011 | Fingolimod -Response According to Coping - Evaluation | A 4-month, Prospective, Open-label, Multi-center Phase IV Study to Assess Response to Fingolimod Initiation According to Coping Profile in Adult Patients With Highly Active Relapsing Remitting Multiple Sclerosis in France | Multiple Sclerosis, Relapsing-Remitting | Drug: fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | Both | 189 | Phase 4 | France |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 911 | EUCTR2009-017978-21-LT (EUCTR) | 25/07/2011 | 30/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 912 | EUCTR2010-020328-23-LV (EUCTR) | 19/07/2011 | 16/05/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Latvia;Norway;Germany;Netherlands | ||
| 913 | EUCTR2011-001160-21-DE (EUCTR) | 18/07/2011 | 20/05/2011 | Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide | Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide treatment and using a population of patients with multiple sclerosis as a reference - TERIVA | Multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Trade Name: Mutagrip Product Name: Mutagrip | sanofi-aventis recherche & developpement | NULL | Not Recruiting | Female: yes Male: yes | 120 | Canada;Ukraine;Austria;Russian Federation;Germany | |||
| 914 | EUCTR2011-001442-15-GB (EUCTR) | 14/07/2011 | 09/06/2011 | A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimod | A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) | relapsing remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Greece;Finland;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Australia;Denmark;Germany;Norway;Sweden | |||
| 915 | EUCTR2009-017978-21-ES (EUCTR) | 13/07/2011 | 17/11/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Pacientes con esclerosis múltiple que hayan participado en estudios con cladribina. MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 916 | EUCTR2009-017978-21-BE (EUCTR) | 12/07/2011 | 29/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United States;United Arab Emirates;Portugal;Serbia;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | |||
| 917 | EUCTR2011-001160-21-AT (EUCTR) | 06/07/2011 | 31/05/2011 | Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide | Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide treatment and using a population of patients with multiple sclerosis as a reference - TERIVA | Multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Trade Name: Mutagrip Product Name: Mutagrip | sanofi-aventis recherche & developpement | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;Russian Federation;Ukraine;Canada;Austria | |||
| 918 | JPRN-UMIN000005889 | 2011/07/01 | 08/07/2011 | The safety and efficacy of tocilizumab in patients with neuromyelitis optica | neuromyelitis optica | Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months. | Department of Immunology, National Institute of Neuroscience, NCNP | NULL | Complete: follow-up complete | 20years-old | 65years-old | Male and Female | 3 | Not applicable | Japan | |
| 919 | NCT01417312 (ClinicalTrials.gov) | July 2011 | 15/8/2011 | Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients | Multiple Sclerosis, Relapsing-Remitting | Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG);Dietary Supplement: Placebo | Charite University, Berlin, Germany | NULL | Completed | 20 Years | 60 Years | All | 20 | N/A | Germany | |
| 920 | EUCTR2011-000926-31-CZ (EUCTR) | 29/06/2011 | 25/05/2011 | A long term, 50 week, Phase IV multi-centre study to determine if Sativex has an effect on cognition (thinking ability) when prescribed to patients with spasticity due to MS | A Multicentre, Double-blind, Randomised Parallel Group, Placebo- controlled Study of the Effect of long-term treatment with Sativex onCognitive Function and Mood of Patients with Spasticity due toMultiple Sclerosis | Spasticity in multiple sclerosis (MS). MedDRA version: 14.1;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray INN or Proposed INN: N/A Other descriptive name: delta-9-tetrahydrocannabinol INN or Proposed INN: N/A Other descriptive name: cannabidiol | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Czech Republic | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 921 | EUCTR2010-020337-99-SK (EUCTR) | 23/06/2011 | 14/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 922 | EUCTR2011-001280-49-FR (EUCTR) | 14/06/2011 | 14/04/2011 | « GRACE : Gilenya® - Réponse Au Coping - Evaluation » Etude clinique menée dans plusieurs centres français, d'une durée de 4 mois, visant à comparer la réponse à l'initiation du traitement par fingolimod (Gilenya®) selon le profil d'anxiété chez des patients adultes présentant une sclérose en plaques rémittente-récurrente très active. | « GRACE : Gilenya® - Réponse Au Coping - Evaluation » Etude multicentrique de phase IV, prospective, en ouvert, d'une durée de 4 mois, visant à comparer la réponse à l’initiation du fingolimod (Gilenya®) selon le profil de « coping » chez des patients adultes présentant une sclérose en plaques rémittente-récurrente très active en France. - GRACE | Sclérose en plaques rémittente-récurrente active MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma S.A.S | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | France | ||
| 923 | EUCTR2009-015318-23-DE (EUCTR) | 09/06/2011 | 08/06/2010 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 924 | EUCTR2009-017978-21-SE (EUCTR) | 08/06/2011 | 03/05/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | |||
| 925 | EUCTR2010-020338-25-DE (EUCTR) | 08/06/2011 | 06/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10 ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10 ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 926 | EUCTR2009-017978-21-FI (EUCTR) | 07/06/2011 | 28/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 927 | EUCTR2009-017978-21-CZ (EUCTR) | 06/06/2011 | 11/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2175 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 928 | EUCTR2010-020338-25-PL (EUCTR) | 04/06/2011 | 14/05/2011 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Norway;Germany;New Zealand | |||
| 929 | EUCTR2009-017978-21-GB (EUCTR) | 03/06/2011 | 11/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 930 | EUCTR2010-020338-25-BE (EUCTR) | 26/05/2011 | 22/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 931 | EUCTR2010-023172-12-AT (EUCTR) | 26/05/2011 | 06/04/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| 932 | EUCTR2011-001956-12-CZ (EUCTR) | 25/05/2011 | 04/05/2011 | Biological Efficacy of Interferon ß Therapy in Patients with Multiple Sclerosis | Monitoring of MxA mRNA Expression as a Marker of Rresponse to Interferon ß Therapy in Patients with Multiple Sclerosis. | To correlate bioactivity of IFNß reflected by level of MxA expression and clinical course of MS To measure expression of MxA protein in patients treated with IFNß depending on NAbs statusNAbs positive cohorts will be correlated NAbs titer with level of MxA expression, respectively if the MxA decrease is not preceding NAbs positivity. The MxA induction test will be tested. | Trade Name: Avonex® Product Name: Avonex® Product Code: EU/1/97/033/002 Trade Name: Betaferon® Product Name: Betaferon® Product Code: EU/1/95/003/005-010 Trade Name: Rebif 22® Product Name: Rebif 22® Product Code: EU/1/98/063/001-003 Trade Name: Rebif 44® Product Name: Rebif 44® Product Code: EU/1/98/063/004-006 Trade Name: Extavia® Product Name: Extavia® Product Code: EU/1/08/454/001-002, EU/1/08/454/005-007 | University Hospital Motol | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Czech Republic | |||
| 933 | EUCTR2009-017978-21-IT (EUCTR) | 16/05/2011 | 05/01/2012 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE). - PREMIERE | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine Tablet INN or Proposed INN: CLADRIBINE Other descriptive name: 2-CdA, 2-chloro-2'-deoxy-ß-D-adenosine | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Portugal;United Arab Emirates;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;India;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United States Minor Outlying Islands;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Bulgaria;Georgia;Germany;Sweden | ||
| 934 | EUCTR2010-020338-25-BG (EUCTR) | 11/05/2011 | 19/01/2011 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: Ro 496-4913/F03 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| 935 | EUCTR2010-020328-23-LT (EUCTR) | 09/05/2011 | 02/03/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oil Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 936 | EUCTR2009-017978-21-LV (EUCTR) | 06/05/2011 | 18/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 937 | EUCTR2009-017978-21-AT (EUCTR) | 05/05/2011 | 31/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | |||
| 938 | NCT01317004 (ClinicalTrials.gov) | May 2011 | 15/3/2011 | Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Standard MS DMT | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 61 | Phase 4 | Italy |
| 939 | NCT01333358 (ClinicalTrials.gov) | May 2011 | 8/4/2011 | Evaluating Alemtuzumab as a Treatment in Stabilizing Neurocognitive Function In Relapsing Remitting Multiple Sclerosis Patients | Phase III A Prospective, Longitudinal, Rater-blinded Single-arm Study to Evaluate Alemtuzumab as an Effective Treatment in Stabilizing Overall Neurocognitive Function in RRMS Subjects at Specified Timepoints | Multiple Sclerosis | Drug: Alemtuzumab | Central Texas Neurology Consultants | Genzyme, a Sanofi Company | Not yet recruiting | N/A | N/A | Both | 30 | Phase 3 | NULL |
| 940 | EUCTR2010-020328-23-EE (EUCTR) | 26/04/2011 | 21/03/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 941 | EUCTR2009-017978-21-EE (EUCTR) | 21/04/2011 | 13/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United Arab Emirates;United States;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 942 | EUCTR2010-023678-38-IT (EUCTR) | 20/04/2011 | 02/02/2011 | High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - ND | High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - ND | patients with multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10028245 | Trade Name: MANTADAN*20CPR 100MG INN or Proposed INN: Amantadine Trade Name: AMPYRA INN or Proposed INN: Ampyra | FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 943 | EUCTR2011-000150-31-IT (EUCTR) | 13/04/2011 | 28/12/2011 | EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY. | EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY. | Multiple Sclerosis patients MedDRA version: 14.1;Level: HLGT;Classification code 10012303;Term: Demyelinating disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate | FONDAZIONE DON CARLO GNOCCHI ONLUS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 944 | EUCTR2011-000770-60-IT (EUCTR) | 12/04/2011 | 01/09/2011 | An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND | An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND | approximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed. MedDRA version: 14.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: fingolimod Product Code: FTY720D INN or Proposed INN: other nervous system drugs | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Italy | |||
| 945 | EUCTR2010-020328-23-BE (EUCTR) | 01/04/2011 | 18/11/2010 | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA-Geneva an affiliate of Merck KgaA, Darmstadt | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 946 | NCT01407211 (ClinicalTrials.gov) | April 2011 | 14/2/2011 | Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient | The Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis | Dietary Supplement: vitamin A | Tehran University of Medical Sciences | NULL | Enrolling by invitation | 20 Years | 45 Years | Both | 30 | Phase 4 | Iran, Islamic Republic of |
| 947 | EUCTR2010-023172-12-PT (EUCTR) | 30/03/2011 | 01/02/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 948 | EUCTR2010-023560-40-SE (EUCTR) | 23/03/2011 | 21/12/2010 | Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed. | Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST | Relapsing-remitting multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Sendoxan Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE Trade Name: Thymoglobuline Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN Trade Name: Neupogen Trade Name: Solu-Medrol | Uppsala l?ns landsting | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | United States;Canada;Brazil;Sweden | |||
| 949 | EUCTR2010-023677-19-IT (EUCTR) | 23/03/2011 | 10/06/2011 | Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010 | Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010 | PATIENT WITH RRMS AND SPMS MedDRA version: 13.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders | Trade Name: BETAFERON*15CONFEZ 0,25MG/ML+ INN or Proposed INN: Interferon beta-1b Trade Name: EXTAVIA*SC 15FL 250MCG/ML+15SI INN or Proposed INN: Interferon beta-1b Trade Name: DIBASE INN or Proposed INN: Colecalciferol | AZIENDA OSPEDALIERA S. LUIGI GONZAGA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 950 | EUCTR2010-023172-12-DK (EUCTR) | 23/03/2011 | 26/04/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 951 | EUCTR2010-024017-31-IT (EUCTR) | 15/03/2011 | 08/02/2011 | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Product Name: FINGOLIMOD Product Code: FTY720D Trade Name: EXTAVIA INN or Proposed INN: Interferon beta-1b Trade Name: AVONEX INN or Proposed INN: Interferon beta-1a Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 952 | EUCTR2010-023172-12-GR (EUCTR) | 15/03/2011 | 27/01/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Other descriptive name: NA Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis group | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 953 | EUCTR2010-023172-12-GB (EUCTR) | 14/03/2011 | 20/12/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 954 | EUCTR2010-020337-99-BG (EUCTR) | 07/03/2011 | 17/12/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 955 | EUCTR2010-023172-12-FI (EUCTR) | 02/03/2011 | 10/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 956 | NCT00813969 (ClinicalTrials.gov) | March 2011 | 22/12/2008 | Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS | A Phase I Study to Assess the Feasibility, Safety, and Tolerability of Autologous Mesenchymal Stem Cell Transplantation in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Progressive Relapsing Multiple Sclerosis | Biological: Autologous mesenchymal stem cell transplantation | The Cleveland Clinic | University Hospital Case Medical Center | Completed | 18 Years | 55 Years | Both | 24 | Phase 1 | United States |
| 957 | NCT01307332 (ClinicalTrials.gov) | March 2011 | 26/1/2011 | Advanced MRI Measures of Repair in Alemtuzumab Treated Patients | Advanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated Patients | Relapsing Remitting Multiple Sclerosis | Drug: MabCampath-1h | University of British Columbia | Genzyme, a Sanofi Company | Completed | 18 Years | 50 Years | All | 27 | Phase 3 | Canada |
| 958 | NCT01328379 (ClinicalTrials.gov) | March 2011 | 29/3/2011 | Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis | Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Doses of Oral Dalfampridine Extended Release Tablets (5 mg and 10 mg Twice Daily) in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Dalfampridine-ER 5mg;Drug: Dalfampridine-ER 10mg;Other: Placebo | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 430 | Phase 3 | United States |
| 959 | EUCTR2010-023172-12-DE (EUCTR) | 25/02/2011 | 05/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | |||
| 960 | EUCTR2010-020337-99-BE (EUCTR) | 23/02/2011 | 12/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 961 | EUCTR2010-023021-38-SE (EUCTR) | 23/02/2011 | 26/11/2010 | Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS | Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS | Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB | Västerbottens läns landsting | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden | |||
| 962 | EUCTR2010-020337-99-CZ (EUCTR) | 21/02/2011 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 963 | EUCTR2010-023172-12-SE (EUCTR) | 18/02/2011 | 07/12/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| 964 | EUCTR2010-023172-12-NL (EUCTR) | 15/02/2011 | 17/11/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | |||
| 965 | EUCTR2010-020515-37-DK (EUCTR) | 14/02/2011 | 03/01/2011 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. - | Relapsing multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Denmark;Estonia;Spain;Greece | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 966 | EUCTR2010-023172-12-ES (EUCTR) | 14/02/2011 | 23/12/2010 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de la teriflunomida en pacientes con esclerosis múltiple recurrente que están en tratamiento con interferón-beta____________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de la teriflunomida en pacientes con esclerosis múltiple recurrente que están en tratamiento con interferón-beta____________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Esclerosis múltiple_______Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 967 | EUCTR2009-017978-21-BG (EUCTR) | 08/02/2011 | 11/09/2015 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | |||
| 968 | EUCTR2010-023172-12-BE (EUCTR) | 08/02/2011 | 29/11/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 969 | EUCTR2010-020337-99-PT (EUCTR) | 04/02/2011 | 29/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Portugal;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 970 | EUCTR2009-010788-18-IT (EUCTR) | 03/02/2011 | 31/05/2011 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - ND | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - ND | Relapsing Remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: MABCAMPATH INN or Proposed INN: Alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Czech Republic;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 971 | NCT02073474 (ClinicalTrials.gov) | February 2011 | 21/2/2014 | An Observational Post-Marketing Safety Registry of Sativex® | An Observational Post-Marketing Safety Registry Of Patients Who Have Been Prescribed Sativex® | Multiple Sclerosis;Diabetes;Cancer;Neuropathic Pain | Drug: Sativex® | GW Pharmaceuticals Ltd. | NULL | Completed | N/A | N/A | All | 978 | N/A | NULL |
| 972 | NCT01285401 (ClinicalTrials.gov) | February 2011 | 26/1/2011 | Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment | A Three Arm, Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study to Evaluate the Efficacy of Vigantol® Oil as Add on Therapy in Subjects With Relapsing Remitting Multiple Sclerosis Receiving Treatment With 44mg Tiw of Rebif® | Relapsing-Remitting Multiple Sclerosis | Drug: VigantOL oil plus interferon beta-1a (Rebif);Drug: Placebo plus interferon beta-1a (Rebif);Biological: Interferon beta-1a (Rebif®) alone | Merck KGaA | NULL | Completed | 18 Years | 55 Years | All | 260 | Phase 2 | Austria;Denmark;Estonia;Finland;Germany;Italy;Latvia;Lithuania;Netherlands;Norway;Portugal;Switzerland;Belgium;Hungary |
| 973 | NCT01281657 (ClinicalTrials.gov) | February 2011 | 19/1/2011 | Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program | A Long Term, Multicenter, Non-interventional, Observational Study Monitoring Long-term Safety and Effectiveness of Fingolimod 0.5 mg in Patients With Multiple Sclerosis Who Have Participated in the Fingolimod Clinical Development Program | Multiple Sclerosis | Drug: fingolimod | Novartis | NULL | Completed | 18 Years | N/A | Both | 64 | N/A | United States;Canada |
| 974 | NCT01310166 (ClinicalTrials.gov) | February 2011 | 24/2/2011 | Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | A 6-month Multicenter, Single-arm, Open-label Study to Investigate Changes in Biomarkers After Initiation of Treatment With 0.5 mg Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | Both | 447 | Phase 4 | Germany |
| 975 | EUCTR2010-020328-23-DE (EUCTR) | 31/01/2011 | 27/10/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Italy;Switzerland;Belgium;Denmark;Germany;Latvia;Netherlands;Norway | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 976 | EUCTR2010-019029-32-SK (EUCTR) | 27/01/2011 | 12/05/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 977 | EUCTR2010-023172-12-SK (EUCTR) | 26/01/2011 | 20/12/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 978 | EUCTR2010-020338-25-AT (EUCTR) | 26/01/2011 | 18/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 979 | EUCTR2010-023172-12-NO (EUCTR) | 25/01/2011 | 03/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Norway;Germany;Sweden | |||
| 980 | EUCTR2010-020338-25-GR (EUCTR) | 21/01/2011 | 17/01/2011 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 981 | EUCTR2010-020337-99-AT (EUCTR) | 20/01/2011 | 18/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 982 | EUCTR2010-020338-25-CZ (EUCTR) | 20/01/2011 | 05/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 983 | EUCTR2010-022066-28-DE (EUCTR) | 18/01/2011 | 29/09/2010 | A 6-month multicenter, single-arm, open-label study to investigate changes in biomarkers after initiation of treatment with 0.5 mg fingolimod (FTY720) in patients with relapsing-remitting multiple sclerosis | A 6-month multicenter, single-arm, open-label study to investigate changes in biomarkers after initiation of treatment with 0.5 mg fingolimod (FTY720) in patients with relapsing-remitting multiple sclerosis | relapsing remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Gilenya Other descriptive name: Fingolimod | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 3 | Germany | ||
| 984 | EUCTR2010-020337-99-LT (EUCTR) | 17/01/2011 | 27/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 985 | EUCTR2010-018705-11-GR (EUCTR) | 14/01/2011 | 31/01/2011 | A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ONO-4641 Product Code: ONO-4641 Product Name: ONO-4641 Product Code: ONO-4641 Product Name: ONO-4641 Product Code: ONO-4641 | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 376 | United States;Czech Republic;Canada;Greece;Spain;Belgium;Ukraine;Russian Federation;Germany;Japan | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 986 | EUCTR2010-023172-12-IT (EUCTR) | 13/01/2011 | 08/02/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta - ND | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta - ND | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245 | Product Name: teriflunomide Product Code: HMR1726 INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726 INN or Proposed INN: teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 987 | EUCTR2010-020338-25-PT (EUCTR) | 12/01/2011 | 14/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: OCREVUS Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;New Zealand | ||
| 988 | EUCTR2010-023172-12-EE (EUCTR) | 12/01/2011 | 14/12/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden;United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation | |||
| 989 | EUCTR2010-023172-12-HU (EUCTR) | 11/01/2011 | 23/11/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1455 | Germany;France;Austria;Sweden;Brazil;Australia;Tunisia;Czech Republic;Canada;Belgium;Korea, Republic of;United States;Greece;Hungary;Portugal;Colombia;Turkey;Netherlands;Chile;Norway;Italy;Lithuania;Finland;United Kingdom;Russian Federation;Slovakia;Guatemala;Denmark;Argentina;Estonia;Spain | |||
| 990 | EUCTR2010-022033-28-NL (EUCTR) | 10/01/2011 | 26/10/2010 | A study investigating safety, tolerability and efficacy of ECP002A (?9-THC) in Multiple Sclerosis patients suffering from spasticity and pain. | A two-phased, randomized, double blind, placebo-controlled study of ECP002A (?9-THC) to determine safety, tolerability and efficacy in Multiple Sclerosis patients suffering from spasticity and pain. - ECP002A (?9-THC) in MS patients | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Namisol Product Code: ECP002A INN or Proposed INN: dronabinol Other descriptive name: Namisol | Echo Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 991 | EUCTR2010-020328-23-NL (EUCTR) | 06/01/2011 | 16/09/2010 | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono The Netherlands - a division of Merck B.V. | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy | ||
| 992 | EUCTR2010-020515-37-IE (EUCTR) | 04/01/2011 | 13/10/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 993 | EUCTR2010-020515-37-CZ (EUCTR) | 03/01/2011 | 27/07/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Romania;Norway;Germany;Sweden;Poland;Belgium;Brazil | ||
| 994 | NCT01252355 (ClinicalTrials.gov) | January 2011 | 30/11/2010 | Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta | A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta | Multiple Sclerosis Relapse | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-beta (IFN-beta) | Sanofi | NULL | Terminated | 18 Years | 55 Years | All | 534 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Colombia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;Italy;Korea, Republic of;Lithuania;Netherlands;Norway;Portugal;Russian Federation;Slovakia;Spain;Sweden;Tunisia;United Kingdom;Turkey |
| 995 | NCT01454791 (ClinicalTrials.gov) | January 2011 | 9/8/2011 | Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate | Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover Trial | Multiple Sclerosis | Drug: diclofenac sodium topical gel;Other: Placebo | Brown, Theodore R., M.D., MPH | Teva Neuroscience, Inc. | Completed | 18 Years | N/A | All | 40 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 996 | NCT01071694 (ClinicalTrials.gov) | January 2011 | 18/2/2010 | QOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon® in Korea | QOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon® in Korea | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046) | Bayer | NULL | Withdrawn | 18 Years | N/A | Both | 0 | N/A | Korea, Republic of |
| 997 | EUCTR2010-020338-25-GB (EUCTR) | 29/12/2010 | 05/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 998 | EUCTR2010-020337-99-LV (EUCTR) | 29/12/2010 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 999 | EUCTR2009-010788-18-AT (EUCTR) | 21/12/2010 | 17/08/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath Product Name: alemtuzumab INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Serbia;United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 1000 | EUCTR2009-017978-21-DE (EUCTR) | 20/12/2010 | 22/11/2010 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1001 | EUCTR2010-020515-37-BE (EUCTR) | 17/12/2010 | 28/10/2010 | Long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety, tolerability and efficacy of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Venezuela, Bolivarian Republic of;Estonia;Slovakia;Greece;Spain;Costa Rica;Ireland;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Norway;Sweden | ||
| 1002 | EUCTR2010-020337-99-FI (EUCTR) | 15/12/2010 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 1003 | EUCTR2010-020338-25-FI (EUCTR) | 15/12/2010 | 15/12/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| 1004 | EUCTR2009-017939-18-GB (EUCTR) | 15/12/2010 | 27/08/2010 | A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with and without Multiple Sclerosis. - Recurrent urine infection in OAB patients with and without MS | A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with and without Multiple Sclerosis. - Recurrent urine infection in OAB patients with and without MS | Chronic urinary tract infection. MedDRA version: 16.1;Level: LLT;Classification code 10059617;Term: Overactive bladder;System Organ Class: 100000004857 | University College London | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | United Kingdom | |||
| 1005 | EUCTR2010-020328-23-DK (EUCTR) | 09/12/2010 | 08/11/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1006 | EUCTR2009-011470-15-NL (EUCTR) | 03/12/2010 | 03/06/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden | |||
| 1007 | EUCTR2010-020515-37-NL (EUCTR) | 01/12/2010 | 12/10/2010 | long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden;Portugal;Comoros;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria | ||
| 1008 | NCT01318421 (ClinicalTrials.gov) | December 2010 | 8/3/2011 | A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis | An Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: ELND002 | Elan Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | Both | 12 | Phase 1 | NULL |
| 1009 | EUCTR2009-010788-18-SE (EUCTR) | 29/11/2010 | 12/08/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: alemtuzumab INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 1010 | EUCTR2007-002627-32-DK (EUCTR) | 29/11/2010 | 20/10/2010 | A study to evaluate how safe and effective 0.5 mg fingolimod is in delaying disability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1011 | EUCTR2010-020337-99-EE (EUCTR) | 26/11/2010 | 27/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 1012 | EUCTR2010-020515-37-FR (EUCTR) | 19/11/2010 | 06/09/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 1013 | EUCTR2010-020338-25-HU (EUCTR) | 17/11/2010 | 29/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: Ro 496-4913/F03 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| 1014 | EUCTR2010-020337-99-HU (EUCTR) | 17/11/2010 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Portugal;United States;Serbia;Estonia;Morocco;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | |||
| 1015 | EUCTR2010-020338-25-LT (EUCTR) | 02/11/2010 | 02/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1016 | NCT02937285 (ClinicalTrials.gov) | November 2010 | 9/9/2016 | National Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple Sclerosis | National Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Beta-1a (REBIF 44mg 3 Times / Week) Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta 1a;Drug: Mitoxantrone | Rennes University Hospital | NULL | Active, not recruiting | 18 Years | 50 Years | All | 266 | Phase 3 | France |
| 1017 | NCT01667796 (ClinicalTrials.gov) | November 2010 | 13/8/2012 | Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health | Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls | Multiple Sclerosis, Relapsing-remitting | Dietary Supplement: Vitamin D3 | Johns Hopkins University | University of California, San Francisco;National Multiple Sclerosis Society | Completed | 18 Years | 60 Years | Female | 57 | N/A | United States |
| 1018 | NCT01236534 (ClinicalTrials.gov) | November 2010 | 4/11/2010 | Lubiprostone in Patients With Multiple Sclerosis Associated Constipation | Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation | Multiple Sclerosis;Constipation | Drug: Lubiprostone;Drug: Placebo | University of Rochester | Takeda | Completed | 18 Years | N/A | All | 21 | Phase 4 | United States |
| 1019 | EUCTR2010-020515-37-IT (EUCTR) | 25/10/2010 | 14/09/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis - ND | MS (MULTIPLE SCLEROSIS) MedDRA version: 9.1;Level: LLT;Classification code 10048393 | Product Name: fingolimod Product Code: FTY720D | NOVARTIS FARMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 5000 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Belgium;Estonia;Spain;Greece | ||||
| 1020 | EUCTR2010-020328-23-FI (EUCTR) | 21/10/2010 | 27/08/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1021 | EUCTR2010-020515-37-AT (EUCTR) | 21/10/2010 | 15/09/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 1022 | EUCTR2010-018705-11-ES (EUCTR) | 20/10/2010 | 27/07/2010 | ESTUDIO DE EXTENSIÓN DE 26 SEMANAS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A 26-WEEK SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS. | ESTUDIO DE EXTENSIÓN DE 26 SEMANAS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A 26-WEEK SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS. | Esclerosis múltiple remitente-recurrente.Relapsing-remitting Multiple Sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: ONO-4641 Product Code: ONO-4641 Product Code: ONO-4641 | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 338 | Czech Republic;Greece;Belgium;Spain;Germany | |||
| 1023 | EUCTR2010-020515-37-SK (EUCTR) | 18/10/2010 | 03/08/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 1024 | EUCTR2010-020515-37-PT (EUCTR) | 11/10/2010 | 23/07/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | |||
| 1025 | EUCTR2010-018705-11-CZ (EUCTR) | 11/10/2010 | 05/08/2010 | A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ONO-4641/MSC2430913A Product Code: ONO-4641/MSC2430913A Product Name: ONO-4641/MSC2430913A Product Code: ONO-4641/MSC2430913A Product Name: ONO-4641/MSC2430913A Product Code: ONO-4641/MSC2430913A | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 376 | United States;Czech Republic;Greece;Canada;Spain;Belgium;Ukraine;Russian Federation;Germany;Japan | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1026 | EUCTR2010-020515-37-EE (EUCTR) | 08/10/2010 | 09/09/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis (LONGTERMS). | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Ireland;Portugal;United States;Estonia;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 1027 | EUCTR2010-019028-30-BE (EUCTR) | 08/10/2010 | 17/08/2010 | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | Relapsing forms of multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | France;Finland;Spain;Belgium;United Kingdom | |||
| 1028 | EUCTR2010-019029-32-BE (EUCTR) | 08/10/2010 | 03/08/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 2 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 1029 | EUCTR2010-020515-37-GR (EUCTR) | 05/10/2010 | 04/10/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 1030 | NCT01005095 (ClinicalTrials.gov) | October 2010 | 29/10/2009 | The Effects of Interferon Beta Combined With Vitamin D on Relapsing Remitting Multiple Sclerosis Patients | A One Year Prospective, Randomized, Double Blind Interventional Study to Assess Tolerability, Quality of Life and Immunomodulation With Interferon Beta Combined With Vitamin D in Patients With Relapsing Remitting Multiple Sclerosis | MULTIPLE SCLEROSIS | Dietary Supplement: Vitamin D3 | Carmel Medical Center | NULL | Terminated | 18 Years | 65 Years | Both | 45 | Phase 4 | Israel |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1031 | NCT01279876 (ClinicalTrials.gov) | October 2010 | 18/1/2011 | Melatonin in Relapsing-Remitting Multiple Sclerosis Patients | Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients | Multiple Sclerosis, Relapsing-Remitting | Drug: Melatonin | Tehran University of Medical Sciences | NULL | Completed | 20 Years | 45 Years | Both | 25 | Phase 2 | Iran, Islamic Republic of |
| 1032 | NCT01166178 (ClinicalTrials.gov) | October 2010 | 19/7/2010 | Zoledronic Acid in MS-patients With Osteoporosis | A 1-year, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Zoledronic Acid 5 mg (Aclasta®) on Bone Mineral Density in Patients With Multiple Sclerosis Followed by a 1-year Open-label Treatment Phase | Osteoporosis;Multiple Sclerosis | Drug: Zoledronic Acid;Drug: Placebo;Dietary Supplement: Calcium and Vitamin D combination | Novartis | NULL | Terminated | 18 Years | 75 Years | All | 29 | Phase 3 | Germany |
| 1033 | NCT01226745 (ClinicalTrials.gov) | October 2010 | 19/10/2010 | Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) | A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: ONO-4641 | EMD Serono | Merck KGaA;Ono Pharmaceutical Co. Ltd | Terminated | 18 Years | 55 Years | All | 340 | Phase 2 | United States;Belgium;Canada;Czech Republic;Germany;Greece;Japan;Poland;Russian Federation;Spain;Ukraine |
| 1034 | EUCTR2010-020515-37-HU (EUCTR) | 30/09/2010 | 11/08/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 1035 | EUCTR2010-020515-37-GB (EUCTR) | 27/09/2010 | 17/08/2010 | Long-term safety and tolerability of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1036 | EUCTR2010-020515-37-SE (EUCTR) | 27/09/2010 | 24/08/2010 | Long-term safety, tolerability and efficacy study of 0.5 mg fingolimodonce daily in patients with multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety, tolerability and efficacy of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with multiple sclerosis. | Multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 1037 | EUCTR2009-010788-18-ES (EUCTR) | 27/09/2010 | 08/01/2010 | Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab. | Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab. | Esclerosis Multiple de Recaida-Remision/Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MABCAMPATH 10 mg/ml concentrado para solución para perfusión INN or Proposed INN: ALEMTUZUMAB Other descriptive name: ALEMTUZUMAB | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Czech Republic;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1038 | EUCTR2009-014392-51-DE (EUCTR) | 20/09/2010 | 03/11/2009 | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapses | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: Siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Hungary;Canada;Finland;Poland;Spain;Turkey;Russian Federation;Germany;Italy | |||
| 1039 | EUCTR2009-011470-15-PL (EUCTR) | 14/09/2010 | 25/05/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden | ||
| 1040 | EUCTR2010-018705-11-BE (EUCTR) | 13/09/2010 | 13/07/2010 | A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ONO-4641/MSC2430913A Product Code: ONO-4641/MSC2430913A Product Name: ONO-4641/MSC2430913A Product Code: ONO-4641/MSC2430913A Product Name: ONO-4641/MSC2430913A Product Code: ONO-4641/MSC2430913A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 376 | United States;Czech Republic;Greece;Canada;Spain;Belgium;Ukraine;Russian Federation;Germany;Japan | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1041 | EUCTR2010-020515-37-DE (EUCTR) | 13/09/2010 | 09/07/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | |||
| 1042 | NCT01201356 (ClinicalTrials.gov) | September 13, 2010 | 10/9/2010 | Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis | A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 4125 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;Egypt;Estonia;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Jordan;Korea, Republic of;Malaysia;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;United Kingdom;Costa Rica;Czech Republic |
| 1043 | EUCTR2009-012500-11-DK (EUCTR) | 08/09/2010 | 04/06/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| 1044 | EUCTR2010-019028-30-FR (EUCTR) | 03/09/2010 | 09/07/2010 | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | Relapsing forms of multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | France;Finland;Belgium;Spain;United Kingdom | |||
| 1045 | EUCTR2010-019029-32-CZ (EUCTR) | 02/09/2010 | 08/06/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Czech Republic;Hungary;Denmark;Germany;Netherlands;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1046 | EUCTR2009-014392-51-HU (EUCTR) | 02/09/2010 | 02/11/2009 | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapses | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: Siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Canada;Finland;Poland;Spain;Turkey;Russian Federation;Germany;Italy | ||
| 1047 | NCT01212094 (ClinicalTrials.gov) | September 2010 | 29/9/2010 | Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe) | Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe) | Multiple Sclerosis | Drug: Rituximab;Other: normal saline | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Terminated | 18 Years | 65 Years | All | 44 | Phase 1;Phase 2 | United States |
| 1048 | EUCTR2009-015318-23-HU (EUCTR) | 31/08/2010 | 14/06/2010 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Czech Republic;Hungary;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 1049 | NCT01185821 (ClinicalTrials.gov) | August 30, 2010 | 19/8/2010 | Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis | A Dose Blinded Extension Study to the CBAF312A2201 Study to Evaluate Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: BAF312 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 56 Years | All | 185 | Phase 2 | United States;Canada;Finland;Germany;Hungary;Italy;Norway;Poland;Russian Federation;Spain;Switzerland;Turkey |
| 1050 | EUCTR2009-012500-11-FR (EUCTR) | 25/08/2010 | 11/01/2010 | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Hungary;Germany;France;Ireland;Italy;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Slovenia;Spain;Greece | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1051 | EUCTR2009-011470-15-DE (EUCTR) | 20/08/2010 | 08/04/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 1052 | EUCTR2009-012500-11-CZ (EUCTR) | 19/08/2010 | 20/01/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| 1053 | EUCTR2009-011470-15-BG (EUCTR) | 12/08/2010 | 30/04/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 1054 | EUCTR2010-020515-37-FI (EUCTR) | 06/08/2010 | 24/06/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 1055 | EUCTR2010-019029-32-NL (EUCTR) | 05/08/2010 | 07/06/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1056 | EUCTR2009-011470-15-AT (EUCTR) | 03/08/2010 | 28/06/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 1057 | EUCTR2010-019029-32-DK (EUCTR) | 02/08/2010 | 25/06/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1058 | NCT01337427 (ClinicalTrials.gov) | August 2010 | 7/4/2011 | Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple Sclerosis | Optical Coherence Tomography (OCT) in a Multicenter, Randomized,Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: BIIB017 | Johns Hopkins University | Biogen Idec | Withdrawn | 18 Years | 55 Years | Both | 0 | Phase 3 | United States |
| 1059 | NCT01191996 (ClinicalTrials.gov) | August 2010 | 30/8/2010 | Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis | A Phase 2, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered MIS416 in Patients With Chronic Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Biological: MIS416 | Innate Immunotherapeutics | Primorus Clinical Trials;National Multiple Sclerosis Society | Completed | 18 Years | N/A | Both | 34 | Phase 1;Phase 2 | New Zealand |
| 1060 | NCT01216072 (ClinicalTrials.gov) | August 2010 | 7/9/2010 | A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC) | Relapsing Forms of Multiple Sclerosis | Drug: Fingolimod;Drug: Standard MS DMTs | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 1053 | Phase 4 | United States;Canada;Puerto Rico |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1061 | NCT01199861 (ClinicalTrials.gov) | August 2010 | 9/9/2010 | Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS) | A 3-month Blinded, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Influenza Vaccination and Tetanus Toxoid Booster Injection in Patients With Relapsing Forms of Multiple Sclerosis (MS) | Relapsing Multiple Sclerosis | Drug: Fingolimod;Drug: Placebo;Biological: Seasonal influenza vaccine;Biological: Tetanus toxoid vaccine | Novartis | NULL | Completed | 18 Years | 55 Years | All | 138 | Phase 3 | Belgium;Canada;Finland;France;Guatemala;Poland;Spain;Switzerland;United Kingdom;Austria |
| 1062 | EUCTR2010-019028-30-GB (EUCTR) | 30/07/2010 | 02/08/2010 | A 3-month blinded, randomized, multicenter, placebo controlled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | A 3-month blinded, randomized, multicenter, placebo controlled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | Relapsing forms of multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Finland;United Kingdom;France;Spain | |||
| 1063 | EUCTR2009-014339-19-DE (EUCTR) | 29/07/2010 | 29/01/2010 | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ONO-4641 Product Code: ONO-4641 Product Name: ONO-4641 Product Code: ONO-4641 Product Name: ONO-4641 Product Code: ONO-4641 | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 376 | United States;Czech Republic;Greece;Canada;Spain;Ukraine;Russian Federation;Germany;Japan | |||
| 1064 | EUCTR2010-019029-32-AT (EUCTR) | 28/07/2010 | 08/06/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1065 | EUCTR2009-011888-37-DE (EUCTR) | 23/07/2010 | 26/03/2010 | A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALT | A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALT | osteoporosis in patients with multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10049088;Term: Osteopenia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10031282;Term: Osteoporosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Aclasta 5 mg Infusionslösung Product Name: Aclasta Product Code: ZOL446H Other descriptive name: ZOLEDRONIC ACID MONOHYDRATE | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase - | Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1066 | EUCTR2010-019029-32-HU (EUCTR) | 21/07/2010 | 31/03/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1850 | Italy;Austria;Hungary;Portugal;Germany;Netherlands;Sweden;Ireland;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1067 | EUCTR2009-009503-19-BE (EUCTR) | 20/07/2010 | 12/05/2009 | A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER | A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: Natalizumab | Biogen Idec International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Belgium | ||
| 1068 | EUCTR2010-019029-32-IE (EUCTR) | 19/07/2010 | 18/05/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1850 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1069 | EUCTR2010-019029-32-GR (EUCTR) | 19/07/2010 | 14/07/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2400 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1070 | EUCTR2009-012500-11-DE (EUCTR) | 13/07/2010 | 20/01/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1071 | EUCTR2009-014339-19-GR (EUCTR) | 13/07/2010 | 04/02/2010 | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: ONO-4641 Product Code: ONO-4641 Product Code: ONO-4641 | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 376 | Germany;Czech Republic;Spain;Greece | |||
| 1072 | EUCTR2009-012500-11-GR (EUCTR) | 13/07/2010 | 17/05/2010 | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Slovenia;Greece;Finland;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden | |||
| 1073 | EUCTR2010-019029-32-SE (EUCTR) | 12/07/2010 | 25/05/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1074 | EUCTR2009-011470-15-HU (EUCTR) | 08/07/2010 | 01/06/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden | ||
| 1075 | EUCTR2010-019028-30-FI (EUCTR) | 07/07/2010 | 27/05/2010 | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | Relapsing forms of multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Finland;United Kingdom;France;Spain | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1076 | EUCTR2010-019029-32-FI (EUCTR) | 07/07/2010 | 28/05/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1077 | NCT01171209 (ClinicalTrials.gov) | July 2010 | 8/7/2010 | REsPonse to Interferon-Alpha in InterfeRon-ß Neutralizing Antibody Positive Multiple Sclerosis Patients | REsPonse to Interferon-Alpha in InterfeRon-ß Neutralizing Antibody Positive Multiple Sclerosis Patients | Multiple Sclerosis | Drug: Interferon-beta and human leukocyte Interferon-a | Melinda Magyari | University of Copenhagen | Completed | 18 Years | 55 Years | Both | 10 | Phase 2 | Denmark |
| 1078 | NCT01207648 (ClinicalTrials.gov) | July 2010 | 21/9/2010 | Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY) | Retrospective Cohort Study of Rebif® Use in Pediatric MS Patients | Multiple Sclerosis | Drug: Rebif® | EMD Serono | NULL | Completed | N/A | 18 Years | All | 307 | N/A | United States;Argentina;Canada;France;Italy;Russian Federation;Tunisia;Venezuela |
| 1079 | NCT01167426 (ClinicalTrials.gov) | July 2010 | 20/7/2010 | Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients | An Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method. | Multiple Sclerosis | Drug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mL | Teva Neuroscience, Inc. | NULL | Completed | 18 Years | N/A | All | 148 | Phase 3 | United States |
| 1080 | EUCTR2009-012500-11-FI (EUCTR) | 29/06/2010 | 22/03/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1081 | EUCTR2009-012500-11-ES (EUCTR) | 24/06/2010 | 12/04/2010 | Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.) | Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.) | Esclerosis Múltiple recidivante-remitente MedDRA version: 11;Level: PT;Classification code 10063399;Term: Esclerosis múltiple remitente-recurrente | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX 30 microgramos/0,5 ml (Interferón Beta - 1a) Solución inyectable INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A | Biogen Idec Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Hungary;Germany;France;Ireland;Italy;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Slovenia;Spain;Greece | |||
| 1082 | EUCTR2009-011470-15-GB (EUCTR) | 22/06/2010 | 29/03/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Sweden;United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands | ||
| 1083 | EUCTR2009-012500-11-IT (EUCTR) | 18/06/2010 | 21/05/2010 | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex (Interferon ß-1a) in Patients with Relapsing Remitting Multiple Sclerosis - ND | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex (Interferon ß-1a) in Patients with Relapsing Remitting Multiple Sclerosis - ND | Relapsing Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Daclizumab HYP Other descriptive name: Daclizumab HYP Trade Name: AVONEX INN or Proposed INN: Interferon beta-1a | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Slovenia;Greece;Finland;Spain;Ireland;Italy;United Kingdom;France;Czech Republic;Hungary;Denmark;Germany;Sweden | |||
| 1084 | EUCTR2009-010788-18-NL (EUCTR) | 07/06/2010 | 18/09/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N.A. | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Serbia;United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 1085 | EUCTR2009-012500-11-SE (EUCTR) | 07/06/2010 | 09/04/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 15.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Slovenia;Finland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1086 | EUCTR2009-012500-11-GB (EUCTR) | 03/06/2010 | 16/04/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab HYP Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | ||
| 1087 | NCT01144052 (ClinicalTrials.gov) | June 2010 | 11/6/2010 | Natalizumab De-escalation With Interferon Beta-1b | De-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: interferon beta-1b;Drug: Natalizumab | Claudio Gobbi | Ospedale Civico, Lugano | Completed | 18 Years | 60 Years | All | 19 | Phase 4 | Switzerland |
| 1088 | EUCTR2010-019029-32-PT (EUCTR) | 31/05/2010 | 07/05/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1850 | Portugal;Hungary;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1089 | EUCTR2008-006786-92-FR (EUCTR) | 27/05/2010 | 06/04/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 1090 | EUCTR2009-013884-21-PL (EUCTR) | 20/05/2010 | 13/01/2010 | A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) | A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) | Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PEG-liposomal Prednisolone Sodium Phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Trade Name: Solu-Medrol INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Enceladus Pharmaceuticals BV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Germany;Belgium;Poland | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1091 | NCT01093326 (ClinicalTrials.gov) | May 12, 2010 | 24/3/2010 | Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis | Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Ponesimod 10 mg;Drug: Ponesimod 20 mg;Drug: Ponesimod 40 mg | Actelion | NULL | Active, not recruiting | 18 Years | 55 Years | All | 353 | Phase 2 | United States;Austria;Bulgaria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Czech Republic |
| 1092 | EUCTR2010-019029-32-GB (EUCTR) | 07/05/2010 | 16/04/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1093 | EUCTR2010-019029-32-DE (EUCTR) | 06/05/2010 | 02/03/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 1094 | EUCTR2007-004452-36-SK (EUCTR) | 06/05/2010 | 11/04/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | |||
| 1095 | EUCTR2009-017490-38-DE (EUCTR) | 03/05/2010 | 01/02/2010 | Randomized Treatment Interruption of Natalizumab - RESTORE | Randomized Treatment Interruption of Natalizumab - RESTORE | Natalizumab is a highly efficacious therapy used in the treatment of patients with relapsing multiple sclerosis (MS).This is a prospective randomized study in subjects with relapsing forms of MS who have been receiving natalizumab treatment for at least 12 months with no MS relapses during these 12 months. MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: TYSABRI Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: COPAXONE Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: AVONEX Trade Name: Urbason Forte INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: URBASON FORTE | Biogen Idec | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;Spain | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1096 | NCT01127750 (ClinicalTrials.gov) | May 2010 | 19/5/2010 | Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients | A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: FTY720 | Novartis | NULL | Completed | 18 Years | 65 Years | All | 2417 | Phase 3 | Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 1097 | NCT01064401 (ClinicalTrials.gov) | May 2010 | 26/1/2010 | Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon ß 1a in Participants With Relapsing-Remitting Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon ß 1a) in Patients With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab High Yield Process);Drug: Interferon beta-1a Placebo;Biological: Interferon beta-1a;Drug: Daclizumab High Yield Process Placebo | Biogen | AbbVie | Completed | 18 Years | 55 Years | All | 1841 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;Czech Republic;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Bulgaria;Egypt;Slovenia |
| 1098 | NCT01076595 (ClinicalTrials.gov) | May 2010 | 25/2/2010 | Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years Period | Prospective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus Program | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 73 | N/A | France |
| 1099 | NCT01354665 (ClinicalTrials.gov) | May 2010 | 16/5/2011 | Depression and Fatigue in MS Patients Treated With Betaferon. | The Short-term Effect of Immunomodulatory Treatment With Interferon Beta-1b (Betaferon) on Fatigue and Depression in First-time Treated Patients With Relapsing-remitting Multiple Sclerosis. | Multiple Sclerosis | Biological: Interferon beta-1b (Betaferon, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 567 | N/A | Poland |
| 1100 | EUCTR2009-011470-15-CZ (EUCTR) | 30/04/2010 | 29/03/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1101 | EUCTR2009-011470-15-IT (EUCTR) | 29/04/2010 | 27/12/2011 | Multicenter, randomized, double-blind, parallel-group extension to study AC-058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ACT-128800, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis. - | Relapsing-remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: ACT-128800 Product Code: ACT-128800 INN or Proposed INN: IMMUNOSUPPRESSIVE AGENTS Product Name: ACT-128800 Product Code: ACT-128800 INN or Proposed INN: IMMUNOSUPPRESSIVE AGENTS Product Name: ACT-128800 Product Code: ACT-128800 INN or Proposed INN: IMMUNOSUPPRESSIVE AGENTS | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;Spain;Italy;Austria;Poland;Sweden | ||||
| 1102 | EUCTR2010-019029-32-IT (EUCTR) | 27/04/2010 | 09/04/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - ND | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - ND | MS (MULTIPLE SCLEROSIS) MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: fingolimod Product Code: FTY720D INN or Proposed INN: fingolimod | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1103 | EUCTR2009-012500-11-IE (EUCTR) | 12/04/2010 | 07/01/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| 1104 | EUCTR2009-011470-15-SE (EUCTR) | 12/04/2010 | 04/03/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 1105 | EUCTR2009-017003-28-IT (EUCTR) | 12/04/2010 | 08/04/2010 | Relationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like Symdrome | Relationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like Symdrome | multiple sclerosis MedDRA version: 9.1;Level: SOC;Classification code 10029205 MedDRA version: 9.1;Level: HLGT;Classification code 10012303 MedDRA version: 9.1;Level: HLT;Classification code 10052785 MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Trade Name: AVONEX INN or Proposed INN: Interferon beta-1a | BIOGEN-DOMPE` SRL | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1106 | EUCTR2009-016824-29-DK (EUCTR) | 06/04/2010 | 25/02/2010 | REsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIR | REsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIR | Multiple Sclerosis MedDRA version: 12.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Multiferon INN or Proposed INN: HUMAN LEUCOCYTE INTERFERON-ALPHA Other descriptive name: HUMAN LEUCOCYTE INTERFERON-ALPHA Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B | Dansk Multipel Sclerose Center | NULL | Not Recruiting | Female: yes Male: yes | 10 | Denmark | |||
| 1107 | EUCTR2009-012500-11-HU (EUCTR) | 31/03/2010 | 24/02/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| 1108 | EUCTR2007-002627-32-HU (EUCTR) | 31/03/2010 | 05/02/2010 | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | Primary progressive multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 940 | France;Czech Republic;Hungary;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 1109 | EUCTR2009-015318-23-GB (EUCTR) | 31/03/2010 | 17/03/2010 | A study designed to determine safety and efficacy of Daclizumab High Yield Process (DAC HYP) in patients with Multiple Sclerosis Who Have Completed Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) - SELECTED | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Biogen | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | |||
| 1110 | EUCTR2009-011470-15-FI (EUCTR) | 30/03/2010 | 09/02/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1111 | EUCTR2008-005167-33-DE (EUCTR) | 29/03/2010 | 16/03/2010 | Effect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease - GABATAX | Effect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease - GABATAX | Patients with cerebellar ataxia with coordination deficits in walking, upper and lower limb movements and oculomtoor coordination deficits are included in the trial. The cause of their atayia is either a degenerative CNS disease (36 patients) such as autosomal dominant Spinocerebellar Ataxia or sporadic ataxia with late onset or inflammatory CNS disease (Multiple Sclerosis; 36 patients). | Trade Name: Neurontin 300 mg hard capsule Product Name: gabapentine 300mg Product Code: GBP INN or Proposed INN: Gabapentin Other descriptive name: GABAPENTIN | Charité University Medicine Berlin | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | |||
| 1112 | EUCTR2009-014339-19-CZ (EUCTR) | 26/03/2010 | 11/01/2010 | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: ONO-4641 Product Code: ONO-4641 Product Code: ONO-4641 | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 376 | Germany;Czech Republic;Spain;Greece | |||
| 1113 | EUCTR2009-011088-35-DE (EUCTR) | 24/03/2010 | 05/02/2010 | Pituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUS | Pituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUS | Patients with Multiple Sclerosis (MS) or Clinically isolated syndrome suggestive for MS (CIS) are investigated. The main objective is to conserve data about changes in the VIP/PACAP (vasoactive intestinal polypaptide/pituitary adenylate cyclase activating polypeptide) system in stresses patients who start a immunomodulatory treatment with glatiramer acetate (Copaxone). | Trade Name: Copaxone Product Name: copaxone Product Code: 52069.00.01 INN or Proposed INN: glatiramer acetate | Philipps-Universität Marburg | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 1114 | EUCTR2009-014339-19-ES (EUCTR) | 18/03/2010 | 20/01/2010 | ESTUDIO DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | ESTUDIO DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Esclerosis múltiple remitente-recurrente.Relapsing-remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: ONO-4641 Product Code: ONO-4641 Product Code: ONO-4641 | ONO Pharmaceutical Co., Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 376 | Germany;Czech Republic;Spain;Greece | |||
| 1115 | EUCTR2009-010788-18-BE (EUCTR) | 16/03/2010 | 12/08/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: alemtuzumab INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1116 | EUCTR2009-014392-51-IT (EUCTR) | 08/03/2010 | 11/12/2009 | A dose blinded extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis. - ND | A dose blinded extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis. - ND | multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 275 | Hungary;Finland;Poland;Spain;Germany;Italy | |||
| 1117 | EUCTR2009-014392-51-PL (EUCTR) | 03/03/2010 | 23/11/2009 | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapses | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: Siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Canada;Finland;Spain;Poland;Turkey;Russian Federation;Germany;Italy | ||
| 1118 | NCT01070836 (ClinicalTrials.gov) | March 2010 | 17/2/2010 | JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab | JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2 | Relapsing Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Completed | N/A | N/A | Both | 35895 | N/A | United States;Puerto Rico |
| 1119 | NCT01097668 (ClinicalTrials.gov) | March 2010 | 31/3/2010 | ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis | SAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS). | Relapsing Remitting Multiple Sclerosis | Biological: ATX-MS-1467 | Apitope Technology (Bristol) Ltd. | Aptiv Solutions;ClinStar, LLC | Completed | 18 Years | 55 Years | All | 43 | Phase 1 | Russian Federation;United Kingdom |
| 1120 | NCT01081782 (ClinicalTrials.gov) | March 2010 | 4/3/2010 | A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis | A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: ONO-4641;Drug: ONO-4641 placebo | Ono Pharma USA Inc | NULL | Completed | 18 Years | 55 Years | Both | 407 | Phase 2 | United States;Belgium;Canada;Czech Republic;Germany;Greece;Japan;Poland;Russian Federation;Spain;Ukraine |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1121 | NCT01144351 (ClinicalTrials.gov) | March 2010 | 9/6/2010 | A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis | A Phase 1b, Dose-Escalating, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: ELND002;Drug: Placebo | Elan Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | Both | 32 | Phase 1 | United States;Canada |
| 1122 | NCT01070823 (ClinicalTrials.gov) | March 2010 | 17/2/2010 | JC-Virus (JCV) Antibody Program | JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1 | Multiple Sclerosis | Drug: Tysabri® (natalizumab) | Biogen | United BioSource Corporation;Elan Pharmaceuticals;United BioSource Corporation;Elan Pharmaceuticals | Completed | N/A | N/A | Both | 1096 | N/A | United States |
| 1123 | NCT01024777 (ClinicalTrials.gov) | March 2010 | 2/12/2009 | Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis | A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis | Multiple Sclerosis;Vitamin D Deficiency | Drug: Cholecalciferol | Johns Hopkins University | NULL | Completed | 18 Years | 55 Years | Both | 40 | Phase 1 | United States |
| 1124 | EUCTR2009-014392-51-FI (EUCTR) | 10/02/2010 | 22/12/2009 | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapses | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: Siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Canada;Finland;Poland;Spain;Turkey;Russian Federation;Germany;Italy | ||
| 1125 | EUCTR2008-006226-34-GB (EUCTR) | 03/02/2010 | 01/11/2010 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE) | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | sanofi-aventis recherche et developpement | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Canada;Belgium;Spain;Germany;Tunisia;Italy;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1126 | EUCTR2009-014857-34-DE (EUCTR) | 01/02/2010 | 21/12/2009 | Intra-individual, randomized multicentric comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in patients with Multiple Sclerosis at 3T - Gadovist in MS | Intra-individual, randomized multicentric comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in patients with Multiple Sclerosis at 3T - Gadovist in MS | Patients with clinically definite MS or a clinically isolated episode of CNS involvement and disease dissemination in space, according to the McDonald’s criteria MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Gadovist 1.0 mmol/ml Injektionslösung Product Code: V08CA09 INN or Proposed INN: GADOBUTROL Other descriptive name: GADOBUTROL Trade Name: Dotarem 0,5mmol/ml, Product Code: V08CA02 INN or Proposed INN: gadoteric acid | Universitätsklinikum Erlangen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Germany | |||
| 1127 | NCT01417273 (ClinicalTrials.gov) | February 2010 | 17/11/2010 | Impact of Vitamin A on Multiple Sclerosis (MS) | Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients | Relapsing Remitting Multiple Sclerosis | Dietary Supplement: vitamin A;Drug: Drug: placebo | Tehran University of Medical Sciences | NULL | Enrolling by invitation | 20 Years | 45 Years | Both | 100 | Phase 4 | Iran, Islamic Republic of |
| 1128 | NCT01705457 (ClinicalTrials.gov) | February 2010 | 9/10/2012 | Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis | Impact of Vitamin A Supplementation on RAR Gene Expression in PBMC Cells in Multiple Sclerotic Patients | Relapsing Remitting Multiple Sclerosis | Drug: Dietary Supplement: vitamin A;Drug: placebo | Tehran University of Medical Sciences | NULL | Enrolling by invitation | 20 Years | 45 Years | Both | 20 | Phase 4 | Iran, Islamic Republic of |
| 1129 | NCT01414634 (ClinicalTrials.gov) | February 2010 | 8/8/2011 | Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells | Establish Tolerance in Multiple Sclerosis With Peptide-coupled, Peripheral Blood Mononuclear Cells - A MRI-controlled, Single Center, Phase I Trial in Relapsing-remitting MS Patients | Multiple Sclerosis, Relapsing-Remitting | Biological: ETIMS | Universitätsklinikum Hamburg-Eppendorf | NULL | Completed | 18 Years | 55 Years | All | 9 | Phase 1;Phase 2 | NULL |
| 1130 | EUCTR2009-012431-15-CZ (EUCTR) | 21/01/2010 | 02/12/2009 | Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®. | Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®. | Studie se zabývá lécbou hyperaktivního neurogeního detruzoru u pacientu, kterí trpí príznaky hyperaktivního mocového mechýre jako dusledek spinálního poranení nebo roztroušené sklerózy. K lécbe se pužívá botulinumotoxin. Ve studii se porovnávaní dve ruzné formy aplikace studjiního léku. | Trade Name: Botox Other descriptive name: BOTULINUM TOXIN TYPE A | Krajská nemocnice Liberec, a.s. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Czech Republic | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1131 | EUCTR2008-004954-34-AT (EUCTR) | 21/01/2010 | 09/12/2008 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | |||
| 1132 | EUCTR2009-015318-23-CZ (EUCTR) | 21/01/2010 | 03/12/2009 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 1133 | EUCTR2009-016140-39-ES (EUCTR) | 19/01/2010 | 28/10/2009 | MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple. | MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple. | Realce de contraste en resonancia magnética enpacientes con Síndrome Clínico Aislado orecaída de Esclerosis Múltiple con resonanciamagnética anormal anterior después de laadministración de dosis única y acumulada deGADOVIST®High field strength MRI in patients with clinically isolated syndromes or relapsing MS with abnormal previous MRI after single and double dose of Gadovist® | Trade Name: GADOVIST 1 mmol/ml solución inyectable en jeringa precargada/ cartucho precargado INN or Proposed INN: GADOBUTROL Other descriptive name: GADOBUTROL | Institut Diagnostic per la Imatge | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 1134 | EUCTR2007-001496-11-GB (EUCTR) | 15/01/2010 | 15/03/2010 | The Effects of Tetanus Vaccination on Mediators of Autoimmunity in Patients with Multiple Sclerosis - Multiple Sclerosis Tetanus Vaccine for Reduction of Inflammation-1 | The Effects of Tetanus Vaccination on Mediators of Autoimmunity in Patients with Multiple Sclerosis - Multiple Sclerosis Tetanus Vaccine for Reduction of Inflammation-1 | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple Sclerosis | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United Kingdom | |||
| 1135 | EUCTR2009-010788-18-DE (EUCTR) | 08/01/2010 | 11/08/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated inGenzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N/A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1136 | NCT01031459 (ClinicalTrials.gov) | January 2010 | 8/12/2009 | Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial. | An Observational 20-year, Cross-sectional, Long-term Follow up of the Patient Cohort Enrolled in the Pivotal Study of Betaseron® (Interferon Beta-1b) in Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Betaseron (Interferon beta-1b, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 176 | N/A | United States;Canada |
| 1137 | NCT01364246 (ClinicalTrials.gov) | January 2010 | 31/5/2011 | Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica | Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica | Progressive Multiple Sclerosis;Neuromyelitis Optica. | Biological: human umbilical cord mesenchymal stem cells | Shenzhen Beike Bio-Technology Co., Ltd. | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School;The Affiliated Nanjing Brain Hospital of Nanjing University Medical School;Nanjing University Medical College Affiliated Wuxi Second Hospital;Xuzhou Medical College;The Second Hospital of Nanjing Medical University | Recruiting | 18 Years | 60 Years | Both | 20 | Phase 1;Phase 2 | China |
| 1138 | NCT01101776 (ClinicalTrials.gov) | January 2010 | 8/4/2010 | Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting. | Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting | Multiple Sclerosis | Drug: Interferon beta-1a (Rebif) | Merck KGaA | Merck Serono Australia Pty Ltd | Completed | 18 Years | N/A | Both | 49 | N/A | Australia |
| 1139 | EUCTR2008-008554-23-SE (EUCTR) | 29/12/2009 | 26/06/2009 | Neutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNF | Neutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNF | IFNß-naïve patients fulfilling Poser or McDonald criteria for CDMS or MS and in whom a decision has been made to initiate treatment with RNF (Rebif New Formulation). MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif Product Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | The Multiple Sclerosis Research Group, Department of Clinical Neuroscience | NULL | Not Recruiting | Female: yes Male: yes | 100 | Sweden | |||
| 1140 | EUCTR2008-006226-34-BE (EUCTR) | 23/12/2009 | 29/09/2009 | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif Product Code: L03 AB INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif Product Name: L03 AB INN or Proposed INN: INTERFERON BETA-1A | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1141 | NCT00963833 (ClinicalTrials.gov) | December 17, 2009 | 21/8/2009 | Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis | Study Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 12 Years | 16 Years | All | 68 | N/A | Austria;Belgium;Finland;Germany;Israel;United Kingdom;Italy;Portugal |
| 1142 | EUCTR2009-013284-19-AT (EUCTR) | 10/12/2009 | 23/11/2009 | Immune tolerance induction in MS patients with neutralizing antibodies against interferon-beta - HINABS | Immune tolerance induction in MS patients with neutralizing antibodies against interferon-beta - HINABS | multiple sclerosis patients with neutralizing antibodies against interferon-beta | Trade Name: Betaferon Other descriptive name: INTERFERON BETA-1B | Medical University Innsbruck | NULL | Not Recruiting | Female: yes Male: yes | Austria | ||||
| 1143 | EUCTR2008-006786-92-PL (EUCTR) | 08/12/2009 | 28/07/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 1144 | NCT01051817 (ClinicalTrials.gov) | December 2009 | 19/1/2010 | POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler | A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis;RRMS | Drug: AIN457;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 73 | Phase 2 | Czech Republic;Russian Federation;Ukraine;Serbia;Sweden |
| 1145 | NCT00986960 (ClinicalTrials.gov) | December 2009 | 29/9/2009 | Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS) | Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up Study | Multiple Sclerosis | Drug: repository corticotropin injection;Drug: Saline | University at Buffalo | NULL | Terminated | 18 Years | 65 Years | All | 3 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1146 | NCT01039103 (ClinicalTrials.gov) | December 2009 | 20/12/2009 | Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS) | A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Relapsing-remitting Multiple Sclerosis or in Patients With Clinically Isolated Syndrome (CIS) | Acute Exacerbation of Remitting Relapsing Multiple Sclerosis;Clinically Isolated Syndrome | Drug: PEG-liposomal prednisolone sodium phosphate;Drug: Methylprednisolone | Galapagos NV | NULL | Terminated | 18 Years | 65 Years | Both | 15 | Phase 2 | Belgium;Germany;Poland |
| 1147 | NCT00913510 (ClinicalTrials.gov) | December 2009 | 3/6/2009 | Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction | Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis | Bladder Dysfunction;Multiple Sclerosis | Device: CIC using LoFric Primo;Drug: Anticholinergic medication | Wellspect HealthCare | NULL | Terminated | 18 Years | N/A | All | 24 | N/A | Belgium;Germany;Netherlands;United Kingdom;France |
| 1148 | EUCTR2008-004408-29-DE (EUCTR) | 27/11/2009 | 31/07/2008 | ESTABLISH TOLERANCE IN MS WITH PEPTIDE-PULSED, PERIPHERAL BLOOD MONONUCLEAR CELLS - A MRI-CONTROLLED, SINGLE CENTER, BASELINE-TO-TREATMENT CROSS-OVER, PHASE I/IIA TRIAL IN RELAPSING-REMITTING MS PATIENTS - ETIMS - - ETIMS | ESTABLISH TOLERANCE IN MS WITH PEPTIDE-PULSED, PERIPHERAL BLOOD MONONUCLEAR CELLS - A MRI-CONTROLLED, SINGLE CENTER, BASELINE-TO-TREATMENT CROSS-OVER, PHASE I/IIA TRIAL IN RELAPSING-REMITTING MS PATIENTS - ETIMS - - ETIMS | relapsing-remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ETIMS (EDC-fixed autologous PBMCs coupled with 7 immunodominant myelin peptides in MS patients) Product Code: ETIMS | University Medical Center Hamburg-Eppendorf | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 1;Phase 2A | Germany | |||
| 1149 | EUCTR2009-010788-18-DK (EUCTR) | 24/11/2009 | 05/10/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Alemtuzumab INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | |||
| 1150 | EUCTR2008-006786-92-BG (EUCTR) | 20/11/2009 | 18/11/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | United Kingdom;Sweden;France;Hungary;Czech Republic;Finland;Poland;Spain;Austria;Bulgaria;Netherlands;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1151 | EUCTR2008-006786-92-AT (EUCTR) | 19/11/2009 | 16/09/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Poland;Austria;Sweden | |||
| 1152 | EUCTR2009-013884-21-DE (EUCTR) | 18/11/2009 | 09/09/2009 | A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) | A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) | Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PEG-liposomal Prednisolone Sodium Phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Trade Name: Solu-Medrol INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Enceladus Pharmaceuticals BV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Poland;Belgium;Germany | |||
| 1153 | EUCTR2009-013884-21-BE (EUCTR) | 13/11/2009 | 10/09/2009 | A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) | A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) | Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: PEG-liposomal Prednisolone Sodium Phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Trade Name: Solu-Medrol INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Poland;Belgium;Germany | ||
| 1154 | EUCTR2008-006786-92-NL (EUCTR) | 03/11/2009 | 18/06/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 1155 | EUCTR2009-010788-18-CZ (EUCTR) | 02/11/2009 | 14/09/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N.A. | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1156 | NCT00950248 (ClinicalTrials.gov) | November 1, 2009 | 30/7/2009 | Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS) | Double Blind Placebo-Controlled Phase I/II Clinical Trial of Idebenone in Patients With Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: Idebenone;Other: placebo | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 65 Years | All | 85 | Phase 1;Phase 2 | United States |
| 1157 | NCT01037907 (ClinicalTrials.gov) | November 2009 | 21/12/2009 | A Study of Orally Administered BGC20-0134 (Structured Lipid) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | A Placebo-controlled Phase IIa Study of Orally Administered BGC20-0134/Pleneva TM (Structured Lipid) in Patients With RRMS | Relapsing Remitting Multiple Sclerosis | Drug: Pleneva TM BGC20-0134;Drug: Placebo | BTG International Inc. | NULL | Terminated | 18 Years | 65 Years | Both | 173 | Phase 2 | Belgium;France;Germany;Poland;Russian Federation;Spain;Italy |
| 1158 | NCT01198132 (ClinicalTrials.gov) | November 2009 | 8/9/2010 | A Multicentre Study of the Efficacy and Safety of Supplementary Treatment With Cholecalciferol in Patients With Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly | A Multicentre, Randomised, Double-blind, Placebo-controlled Study of the Efficacy of Supplementary Treatment With Cholecalciferol (Vitamin D3) in Patients With Relapsing- Multiple Sclerosis (RMS) Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly | Multiple Sclerosis | Dietary Supplement: Cholecalciferol (Vitamin D3);Dietary Supplement: Placebo;Drug: Rebif | Merck KGaA | Merck Serono S.A.S, France | Completed | 18 Years | 65 Years | All | 129 | Phase 2 | France |
| 1159 | NCT01144117 (ClinicalTrials.gov) | November 2009 | 7/6/2010 | The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis | Double Blind, Placebo-controlled Study to Assess the Effects of Erythropoietin on Clinical Disability and Brain Pathology as Shown by Magnetic Resonance Imaging in Patients With Progressive Multiple Sclerosis | Multiple Sclerosis (Primary or Secondary Progressive Phase). | Drug: Erythropoietin | Rigshospitalet, Denmark | Danish Research Centre for Magnetic Resonance | Recruiting | 19 Years | 60 Years | Both | 56 | Phase 2 | Denmark |
| 1160 | EUCTR2009-011585-28-ES (EUCTR) | 30/10/2009 | 24/08/2009 | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS)Estudio fase IIa, aleatorizado, doble ciego, controlado con placebo, de BGC20-0134 administrado de forma oral en pacientes con esclerosis múltiple recurrente remitente (EMRR)? | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS)Estudio fase IIa, aleatorizado, doble ciego, controlado con placebo, de BGC20-0134 administrado de forma oral en pacientes con esclerosis múltiple recurrente remitente (EMRR)? | Esclerosis Múltiple Recurrente-RemitenteRelapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BGC20-0134 Product Code: BGC20-0134 Other descriptive name: Glicerol-1,3-didecanoato-2-octadeca-(6Z,9Z,12Z)-trienoato | BTG International Ltd | NULL | Not Recruiting | Female: yes Male: yes | 166 | Phase 2a | Germany;Belgium;France;Spain | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1161 | EUCTR2009-011626-34-SE (EUCTR) | 28/10/2009 | 20/07/2009 | A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 | A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class) | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | Czech Republic;Sweden | |||
| 1162 | EUCTR2009-013695-46-FR (EUCTR) | 22/10/2009 | 07/09/2009 | ETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - choline | ETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - choline | Sclérose en plaques récurrente (SEP-R) MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: UVEDOSE 100 000 UI, solution buvable en ampoule Product Name: UVEDOSE 100 000 UI INN or Proposed INN: COLECALCIFEROL | MERCK SERONO s.a.s | NULL | Not Recruiting | Female: yes Male: yes | France | ||||
| 1163 | EUCTR2008-006786-92-BE (EUCTR) | 22/10/2009 | 24/09/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Netherlands;Sweden | ||
| 1164 | EUCTR2009-011585-28-FR (EUCTR) | 21/10/2009 | 05/08/2009 | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BCG20-0134 Product Code: BCG20-0134 Other descriptive name: Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate | BTG International Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 2a | Germany;Belgium;France;Spain | ||
| 1165 | EUCTR2008-005021-11-BE (EUCTR) | 14/10/2009 | 12/12/2008 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA - Geneva, An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 68 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1166 | EUCTR2006-003361-14-CZ (EUCTR) | 12/10/2009 | 05/05/2009 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 1167 | EUCTR2009-011585-28-DE (EUCTR) | 08/10/2009 | 07/07/2009 | Early phase clinical trial to evaluate the effectiveness and safety of a new orally administered drug in patients with relapsing-remitting multiple sclerosis | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | relapsing-remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BCG20-0134 Product Code: BCG20-0134 Other descriptive name: Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate | BTG International Ltd | NULL | Not Recruiting | Female: yes Male: yes | 184 | Phase c | France;European Union;Spain;Belgium;Russian Federation;Germany | ||
| 1168 | NCT01006265 (ClinicalTrials.gov) | October 1, 2009 | 30/10/2009 | Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: ACT-128800 Dose 1;Drug: Placebo;Drug: ACT-128800 Dose 2;Drug: ACT-128800 Dose 3 | Actelion | NULL | Completed | 18 Years | 55 Years | All | 464 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom |
| 1169 | NCT02275741 (ClinicalTrials.gov) | October 2009 | 22/10/2014 | Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis | Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: prophylactic vaccine (tetanus, diphtheria, pertussis, poliomyelitis, influenza, hepatitis A, hepatitis B, tick-borne encephalitis, meningococcal, pneumococcal) | Dr. med. Micha Loebermann | NULL | Completed | 18 Years | 70 Years | All | 226 | Germany | |
| 1170 | NCT01225289 (ClinicalTrials.gov) | October 2009 | 6/9/2010 | Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients | The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Dietary Supplement: Vitamin A;Drug: Placebo | Tehran University of Medical Sciences | NULL | Completed | 20 Years | 45 Years | All | 36 | Phase 4 | Iran, Islamic Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1171 | EUCTR2008-006786-92-IT (EUCTR) | 29/09/2009 | 10/08/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis. - ND | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis. - ND | Multiple Sclerosis Relapsing Remitting MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 1172 | EUCTR2009-011585-28-BE (EUCTR) | 28/09/2009 | 13/07/2009 | Early phase clinical trial to evaluate the effectiveness and safety of a new orally administered drug in patients with relapsing-remitting multiple sclerosis | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | relapsing-remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: BCG20-0134 Product Code: BCG20-0134 Other descriptive name: Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate | BTG International Ltd | NULL | Not Recruiting | Female: yes Male: yes | 184 | Phase 2 | France;European Union;Spain;Belgium;Russian Federation;Germany | ||
| 1173 | EUCTR2006-003361-14-EE (EUCTR) | 25/09/2009 | 19/08/2009 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;Estonia;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 1174 | EUCTR2009-011626-34-CZ (EUCTR) | 21/09/2009 | 27/07/2009 | A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 | A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 | Relapsing-remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class) | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Russian Federation;Czech Republic;Ukraine;Serbia;Sweden | |||
| 1175 | EUCTR2008-006786-92-HU (EUCTR) | 18/09/2009 | 02/06/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Finland;Hungary;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1176 | EUCTR2006-001152-12-DE (EUCTR) | 14/09/2009 | 04/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 1177 | EUCTR2008-004954-34-PL (EUCTR) | 09/09/2009 | 05/06/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 1178 | NCT00910598 (ClinicalTrials.gov) | September 2009 | 29/5/2009 | Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS) | A Multicenter Longitudinal Cross-sectional Pilot Study, to Compare RNFL Thickness Measured by OCT After Treatment With Glatiramer or After no Treatment in Patients With CIS With or Without Optic Neuritis or With Early RRMS | Multiple Sclerosis | Drug: glatiramer acetate | Amphia Hospital | Sanofi;TEVA Pharmachemie | Recruiting | 18 Years | 55 Years | Both | 60 | Phase 4 | Netherlands |
| 1179 | EUCTR2007-004452-36-SE (EUCTR) | 20/08/2009 | 24/06/2009 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | ||
| 1180 | EUCTR2008-008719-25-FI (EUCTR) | 13/08/2009 | 19/02/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Name: BAF312 Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Finland;Germany;Spain;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1181 | EUCTR2008-005021-11-SE (EUCTR) | 12/08/2009 | 13/05/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| 1182 | NCT00930553 (ClinicalTrials.gov) | August 2009 | 26/6/2009 | An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | Multiple Sclerosis, Relapsing-Remitting | Biological: alemtuzumab | Genzyme, a Sanofi Company | Bayer | Completed | N/A | N/A | All | 1314 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czechia;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom;Czech Republic |
| 1183 | NCT00871780 (ClinicalTrials.gov) | August 2009 | 26/3/2009 | A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients | A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients TIMER Study | Relapsing Remitting Multiple Sclerosis (RRMS) | Drug: BG00002 (natalizumab) | Biogen | Elan Pharmaceuticals | Completed | 18 Years | 60 Years | All | 224 | Phase 4 | Belgium;Mexico;Poland;Romania;Saudi Arabia;Ukraine;Venezuela |
| 1184 | EUCTR2008-005021-11-CZ (EUCTR) | 22/07/2009 | 08/06/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| 1185 | EUCTR2009-013129-41-NL (EUCTR) | 20/07/2009 | 03/06/2009 | A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCT | A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCT | clinical isolated syndrome MedDRA version: 9.1;Level: LLT;Classification code 10028248;Term: Multiple sclerosis-like syndrome | Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Amphia Ziekenhuis | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1186 | EUCTR2008-006226-34-GR (EUCTR) | 20/07/2009 | 19/03/2009 | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE | Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Czech Republic;Hungary;Greece;Belgium;Spain;Germany;United Kingdom;Italy | ||
| 1187 | EUCTR2008-006786-92-GB (EUCTR) | 17/07/2009 | 27/04/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 1188 | EUCTR2008-006786-92-SE (EUCTR) | 16/07/2009 | 08/05/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | France;Hungary;Czech Republic;Finland;Poland;Spain;Austria;Bulgaria;Netherlands;Italy;United Kingdom;Sweden | |||
| 1189 | EUCTR2008-006786-92-FI (EUCTR) | 06/07/2009 | 01/04/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 1190 | EUCTR2008-002626-11-SE (EUCTR) | 02/07/2009 | 24/04/2009 | Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis | Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis - PMSIT | Severe progressive multiple sclerosis in which there is no other documented treatment avalilable or allready tested. It is estimated that the prognosis for these patients are poor without any effective treatment MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Mabthera Other descriptive name: RITUXIMAB | Dept of Neurology | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1191 | EUCTR2009-010788-18-GB (EUCTR) | 01/07/2009 | 13/07/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | |||
| 1192 | EUCTR2009-011523-31-GB (EUCTR) | 23/06/2009 | 16/04/2009 | A study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VAC | A study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VAC | The vaccinations are being used to investigate immunological memory following treatment of multiple sclerosis with the lympho-depleting humanised monoclonal antibody alemtuzumab. MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10046859;Term: Vaccination | Trade Name: Menitorix Trade Name: Pneumovax II Trade Name: REVAXIS | R & D, Cambridge University Hospitals | NULL | Not Recruiting | Female: yes Male: yes | 60 | United Kingdom | |||
| 1193 | EUCTR2006-001152-12-LT (EUCTR) | 22/06/2009 | 31/03/2009 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 1194 | EUCTR2008-006786-92-CZ (EUCTR) | 18/06/2009 | 26/03/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 1195 | EUCTR2008-006226-34-CZ (EUCTR) | 08/06/2009 | 02/03/2009 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE) | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | sanofi-aventis recherche et developpement | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Hungary;Czech Republic;Canada;Belgium;Spain;Germany;Tunisia;United Kingdom;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1196 | NCT00917839 (ClinicalTrials.gov) | June 2009 | 9/6/2009 | The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis | Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis. | Relapsing-Remitting Multiple Sclerosis | Drug: lamotrigine | Cantonal Hospital of St. Gallen | NULL | Recruiting | 18 Years | 50 Years | Both | 88 | Phase 2 | Switzerland |
| 1197 | NCT00942214 (ClinicalTrials.gov) | June 2009 | 16/7/2009 | Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatment | Biomarkers Associated With Response to Natalizumab in Multiple Sclerosis Patients. A Prospective Multicentric Open Label Phase IV Study | Multiple Sclerosis | Drug: Natalizumab | University Hospital, Toulouse | NULL | Completed | 18 Years | 55 Years | Both | 300 | Phase 4 | France |
| 1198 | EUCTR2009-011516-37-DK (EUCTR) | 29/05/2009 | 15/05/2009 | Double blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMS | Double blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMS | Multiple Sclerosis, with primary and secondary progressive courses. MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: NeoRecormon INN or Proposed INN: Solu-Medrol Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Danish Multiple Sclerosis Research Centre | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 1199 | EUCTR2008-004954-34-BG (EUCTR) | 28/05/2009 | 29/05/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | |||
| 1200 | EUCTR2008-005021-11-FR (EUCTR) | 26/05/2009 | 24/03/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1201 | EUCTR2007-004122-24-EE (EUCTR) | 25/05/2009 | 23/04/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720 INN or Proposed INN: fingolimod Product Name: FTY720 Product Code: FTY720 INN or Proposed INN: fingolimod | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 1202 | EUCTR2007-004122-24-IE (EUCTR) | 22/05/2009 | 04/03/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod INN or Proposed INN: fingolimod | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 1203 | EUCTR2008-004954-34-GR (EUCTR) | 19/05/2009 | 06/03/2009 | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono International, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia | |||
| 1204 | EUCTR2008-006226-34-DE (EUCTR) | 14/05/2009 | 03/02/2009 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE) | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | sanofi-aventis recherche et developpement | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy | |||
| 1205 | EUCTR2008-008719-25-HU (EUCTR) | 12/05/2009 | 11/03/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Finland;Hungary;Germany;Spain;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1206 | EUCTR2008-004954-34-DE (EUCTR) | 05/05/2009 | 15/01/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 1207 | EUCTR2007-002627-32-GB (EUCTR) | 05/05/2009 | 18/04/2008 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - Efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | Phase 3 | United States;Finland;Spain;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | |||
| 1208 | EUCTR2008-006226-34-FR (EUCTR) | 04/05/2009 | 25/03/2009 | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENERE | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENERE | Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif | sanofi-aventis Recherche & Dévelopment | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;United Kingdom;Czech Republic;Germany;France;Spain;Italy | |||
| 1209 | NCT01075880 (ClinicalTrials.gov) | May 2009 | 24/2/2010 | Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif® | Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With Rebif | Multiple Sclerosis, Relapsing-Remitting | Drug: Rebif (Interferon beta-1a) | Merck KGaA | Merck spol.s.r.o., Czech Republic | Completed | 18 Years | 65 Years | Both | 300 | N/A | Czech Republic |
| 1210 | NCT00902135 (ClinicalTrials.gov) | May 2009 | 13/5/2009 | Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH) | Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH) | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 702 | N/A | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1211 | NCT00854750 (ClinicalTrials.gov) | May 2009 | 27/2/2009 | Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis | Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis | Multiple Sclerosis | Drug: ACTHAR | Elliot Frohman | Questcor Pharmaceuticals, Inc. | Terminated | 18 Years | 65 Years | Both | 1 | Phase 4 | United States |
| 1212 | NCT00799890 (ClinicalTrials.gov) | May 2009 | 28/11/2008 | Sunphenon in Progressive Forms of Multiple Sclerosis | Monocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Sunphenon EGCG;Drug: Placebo | Friedemann Paul | TAIYO EUROPE | Completed | 18 Years | 65 Years | All | 61 | Phase 2;Phase 3 | Germany |
| 1213 | EUCTR2007-004122-24-HU (EUCTR) | 23/04/2009 | 16/02/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Hungary;Czech Republic;Belgium;Netherlands;Germany;Sweden | |||
| 1214 | EUCTR2008-001999-67-DE (EUCTR) | 23/04/2009 | 16/03/2009 | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | France;Finland;Spain;Germany | |||
| 1215 | EUCTR2007-004452-36-AT (EUCTR) | 14/04/2009 | 14/04/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Chile;France;Australia;Tunisia;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1216 | EUCTR2008-004954-34-IT (EUCTR) | 08/04/2009 | 12/03/2009 | Double-Blind Extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with rebif New Formulation (REFLEXION) - REFLEXION | Double-Blind Extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with rebif New Formulation (REFLEXION) - REFLEXION | Subjects at high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: REBIF*SC 12SIR 12000000UI44MCG INN or Proposed INN: Interferon beta-1a | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia | |||
| 1217 | EUCTR2008-004954-34-FR (EUCTR) | 08/04/2009 | 17/03/2009 | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A.- Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 492 | Belgium;Portugal;Germany;France;Bulgaria;Italy;Latvia;Austria;Finland;Czech Republic;Estonia;Spain;Greece;Poland | |||
| 1218 | EUCTR2007-004122-24-FI (EUCTR) | 08/04/2009 | 04/06/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 1219 | EUCTR2008-008719-25-IT (EUCTR) | 08/04/2009 | 06/03/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsingremitting multiple sclerosis - ND | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsingremitting multiple sclerosis - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Finland;Germany;Spain;Italy | ||
| 1220 | EUCTR2008-007447-14-IT (EUCTR) | 03/04/2009 | 26/03/2009 | GH-IGF-I status and Multiple Sclerosis: clinical implications (a prevalence study). | GH-IGF-I status and Multiple Sclerosis: clinical implications (a prevalence study). | patients with Multiple Sclerosis MedDRA version: 14.1;Level: SOC;Classification code 10022891;Term: Investigations;System Organ Class: 10022891 - Investigations MedDRA version: 14.1;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | INN or Proposed INN: Somatorelin | UNIVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1221 | NCT00883337 (ClinicalTrials.gov) | April 2009 | 16/4/2009 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period | Multiple Sclerosis | Drug: Interferon ß-1a;Drug: Teriflunomide | Sanofi | NULL | Completed | 18 Years | N/A | All | 324 | Phase 3 | Belgium;Canada;Czech Republic;France;Germany;Greece;Hungary;Italy;Poland;Spain;Switzerland;Tunisia;United Kingdom |
| 1222 | NCT01567553 (ClinicalTrials.gov) | April 2009 | 24/2/2012 | The Inflammatory Process and the Medical Imaging in Patients With an Inflammatory Disease of the Central Nervous System. | Early Neuroinflammatory Changes as a Prognostic Marker in Clinically Isolated Syndromes Patients. | Multiple Sclerosis (MS);Inflammatory Disease | Other: USPIO MRI - Gadolinium MRI | Rennes University Hospital | Bayer;Bayer | Terminated | 18 Years | 45 Years | Both | 37 | N/A | France |
| 1223 | NCT00881205 (ClinicalTrials.gov) | April 2009 | 14/4/2009 | Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment | A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Rivastigmine Patch (10 cm²) on Cognitive Deficits in Patients With Multiple Sclerosis, Followed by a 1-year Open-label Treatment Phase | Multiple Sclerosis;Cognitive Impairment | Drug: Rivastigmine transdermal patch;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 86 | Phase 4 | Germany |
| 1224 | NCT00879658 (ClinicalTrials.gov) | March 30, 2009 | 9/4/2009 | Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis | A Phase II, Double-blind, Randomized, Multi-center, Adaptive Dose-ranging, Placebo-controlled, Parallel-group Study Evaluating Safety, Tolerability and Efficacy on MRI Lesion Parameters and Determining the Dose Response Curve of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis. | Relapsing-remitting Multiple Sclerosis | Drug: BAF312;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 297 | Phase 2 | United States;Canada;Finland;Germany;Hungary;Italy;Norway;Poland;Russian Federation;Spain;Switzerland;Turkey |
| 1225 | EUCTR2008-006226-34-ES (EUCTR) | 25/03/2009 | 23/01/2009 | Estudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante------------------------------------------------------------A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE | Estudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante------------------------------------------------------------A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE | Esclerosis Múltiple------------------------Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: REBIF 44 microgramos solución inyectable INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1226 | EUCTR2007-004452-36-GB (EUCTR) | 24/03/2009 | 01/02/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis using interferon-beta 1a (Rebif®) as an open-label rater-blind calibrator | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis using interferon-beta 1a (Rebif®) as an open-label rater-blind calibrator | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | Belarus;United States;Philippines;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Chile;France;Australia;Netherlands;Tunisia;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Germany;Sweden | ||
| 1227 | NCT00884481 (ClinicalTrials.gov) | March 23, 2009 | 17/4/2009 | Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS | A Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 Months | Relapsing-Remitting Multiple Sclerosis;Fatigue | Other: Natalizumab | Biogen | NULL | Completed | 18 Years | 65 Years | All | 195 | Austria;Denmark;Norway;Sweden;United States | |
| 1228 | EUCTR2008-001999-67-FI (EUCTR) | 19/03/2009 | 28/01/2009 | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | Finland;Germany;France;Spain | |||
| 1229 | EUCTR2008-002096-27-AT (EUCTR) | 19/03/2009 | 09/07/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis with optional extension phase - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis with optional extension phase - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase - | United Kingdom;Poland;Austria;Lithuania | ||
| 1230 | EUCTR2008-001999-67-FR (EUCTR) | 16/03/2009 | 03/02/2009 | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Finland;Germany;France;Spain | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1231 | EUCTR2008-008065-35-SE (EUCTR) | 13/03/2009 | 17/12/2008 | A multi-centre and prospective trial to evaluate the effects on mul-tiple sclerosis related fatigue during treatment with Tysabri® in patients with relapsing remitting multiple sclerosis over the course of 12 months - TYNERGY | Mutiple sclerosis related fatigue in subjects with relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10016256;Term: Fatigue | Trade Name: Tysabri | BiogenIdec A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | Sweden | ||||
| 1232 | EUCTR2008-004954-34-LV (EUCTR) | 12/03/2009 | 27/02/2009 | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Latvia;Germany | |||
| 1233 | EUCTR2008-004954-34-BE (EUCTR) | 09/03/2009 | 23/01/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1234 | EUCTR2006-001827-21-DK (EUCTR) | 06/03/2009 | 15/01/2009 | A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 monthsStudy Phase: III - Simvastatin/Copaxone | A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 monthsStudy Phase: III - Simvastatin/Copaxone | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Simvastatin Trade Name: Copaxone Product Name: Glatiramer acetate | Glostrup Hospital, Dep. of Neurology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Denmark | ||||
| 1235 | EUCTR2008-004174-40-FR (EUCTR) | 06/03/2009 | 25/11/2008 | Imagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEP | Imagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEP | Groupe I: volontaires sainsGroupe II: patients avec une sclérose en plaques d'évolution rémittente . MedDRA version: 8.1;Level: PT;Classification code 10012300;Term: Demyelinating disease (excl multiple sclerosis) | Product Name: 11C-PIB INN or Proposed INN: 11C-PIB | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1236 | EUCTR2008-006226-34-IT (EUCTR) | 05/03/2009 | 09/03/2009 | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENERE | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENERE | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399 MedDRA version: 9.1;Classification code 10028245 | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: REBIF INN or Proposed INN: interferone | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy | |||
| 1237 | EUCTR2008-006226-34-HU (EUCTR) | 05/03/2009 | 09/02/2009 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE) | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | sanofi-aventis recherche et developpement | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Canada;Belgium;Spain;Germany;Tunisia;United Kingdom;Italy | |||
| 1238 | EUCTR2008-004954-34-SK (EUCTR) | 05/03/2009 | 09/09/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | ||
| 1239 | NCT02021825 (ClinicalTrials.gov) | March 2009 | 3/9/2013 | Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders | Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorders | Drug: Mitoxantrone | Xuanwu Hospital, Beijing | NULL | Recruiting | 18 Years | 55 Years | Both | 50 | Phase 4 | China |
| 1240 | NCT00818038 (ClinicalTrials.gov) | March 2009 | 5/1/2009 | A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder Function | Phase IV, Proof of Concept Study to Evaluate Tysabri Effectiveness in RRMS Patient Bladder Function | Relapsing-Remitting Multiple Sclerosis | Drug: BG0002 (natalizumab) | Biogen Idec | NULL | Completed | 18 Years | 85 Years | Both | 30 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1241 | EUCTR2007-003086-40-BE (EUCTR) | 25/02/2009 | 21/11/2007 | A Phase I/II study of Pixantrone in Patients with an Aggressive Relapsing Remitting (RR) or Secondary Progressive (SP) Multiple Sclerosis (PIXAMS) | A Phase I/II study of Pixantrone in Patients with an Aggressive Relapsing Remitting (RR) or Secondary Progressive (SP) Multiple Sclerosis (PIXAMS) | aggressive relapsing remitting (RR) or secondary progressive (SP) multiple sclerosis | Product Name: Pixantrone Product Code: BBR 2778 INN or Proposed INN: Pixantrone | Fondation Charcot Stichting | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Belgium;France | ||
| 1242 | EUCTR2007-004452-36-GR (EUCTR) | 17/02/2009 | 18/02/2009 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | ||
| 1243 | EUCTR2008-000256-26-GB (EUCTR) | 16/02/2009 | 08/12/2010 | An exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®) - Tolerance induction with intravenous IFNß-1a | An exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®) - Tolerance induction with intravenous IFNß-1a | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Mitoxantrone Product Name: Mitoxantrone Product Code: PL 04515/0127 Trade Name: Rebif® INN or Proposed INN: Mitoxantrone | Queen Mary, University of London | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2a | United Kingdom | ||
| 1244 | EUCTR2008-004954-34-EE (EUCTR) | 13/02/2009 | 08/01/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | |||
| 1245 | EUCTR2008-005304-93-GB (EUCTR) | 13/02/2009 | 12/12/2008 | A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis | A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis | Bone loss in patients with Multiple Sclerosis (MS) who require large short term doses of methylprednisolone for exacerbations of their disease. MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse MedDRA version: 9.1;Classification code 10065687;Term: Bone loss | Trade Name: Aclasta 5mg solution for infusion Product Name: Aclasta Product Code: ZOL446H | North Bristol Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1246 | EUCTR2008-004954-34-PT (EUCTR) | 06/02/2009 | 05/01/2009 | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia | ||
| 1247 | EUCTR2007-002627-32-CZ (EUCTR) | 04/02/2009 | 09/04/2008 | efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;South Africa;Netherlands;Germany;Sweden | |||
| 1248 | NCT03408093 (ClinicalTrials.gov) | February 3, 2009 | 8/1/2018 | Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b | Cross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1b | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 100 Years | All | 120 | NULL | |
| 1249 | EUCTR2008-001999-67-ES (EUCTR) | 30/01/2009 | 17/11/2008 | Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Esclerosis Múltiple______________Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Finland;Germany;France;Spain | |||
| 1250 | EUCTR2008-004954-34-FI (EUCTR) | 26/01/2009 | 17/12/2008 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1251 | EUCTR2007-004122-24-GR (EUCTR) | 13/01/2009 | 30/01/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 1252 | EUCTR2007-001377-28-PT (EUCTR) | 09/01/2009 | 25/08/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 1253 | EUCTR2007-004223-38-GB (EUCTR) | 05/01/2009 | 26/11/2007 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | GlaxoSmithKline UK | NULL | Not Recruiting | Female: yes Male: yes | 57 | Phase 2 | Czech Republic;Belgium;Denmark;Germany;United Kingdom;Sweden | |||
| 1254 | NCT00876447 (ClinicalTrials.gov) | January 1, 2009 | 1/4/2009 | A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis | Overactive Bladder | Biological: Botulinum Toxin Type A 300U;Biological: Botulinum Toxin Type A 200U | Allergan | NULL | Completed | 18 Years | N/A | All | 397 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Italy;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Singapore;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Czech Republic | |
| 1255 | NCT01031199 (ClinicalTrials.gov) | January 2009 | 11/12/2009 | Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers | Open-label, Non-randomized, Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 140 MBq (ca. 5 mSv) ZK 6032924 (BAY85-8101) for Its Diagnostic Potential in Either Drug-naïve or Specifically (IFN-beta) Pretreated Patients With Multiple Sclerosis (MS) With Acute Relapse or Patients With Clinically Isolated Syndrome (CIS), Compared to Healthy Volunteers | Positron-Emission Tomography;Multiple Sclerosis | Drug: F-18 FEDAA1106 (BAY85-8101) | Bayer | NULL | Completed | 20 Years | 55 Years | Both | 16 | Phase 1 | Australia;Sweden |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1256 | EUCTR2008-002096-27-LT (EUCTR) | 22/12/2008 | 16/07/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United Kingdom;Austria;Poland;Lithuania | |||
| 1257 | EUCTR2008-004954-34-CZ (EUCTR) | 12/12/2008 | 21/11/2008 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 1258 | EUCTR2007-004452-36-ES (EUCTR) | 04/12/2008 | 23/09/2008 | Estudio multicéntrico, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de teriflunomida en pacientes con esclerosis múltiple recurrente_________________________________________________________________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Estudio multicéntrico, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de teriflunomida en pacientes con esclerosis múltiple recurrente_________________________________________________________________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Esclerosis múltiple_____________Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Sweden | |||
| 1259 | EUCTR2007-004452-36-FR (EUCTR) | 02/12/2008 | 21/10/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | |||
| 1260 | NCT00813709 (ClinicalTrials.gov) | December 2008 | 22/12/2008 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind Extension of the Study 27025 (REFLEX) to Obtain Long-term Follow-up Data in Patients With Clinically Definite MS and Patients With a First Demyelinating Event at High Risk of Converting to MS, Treated With Rebif® New Formulation (REFLEXION) | Multiple Sclerosis;Clinically Isolated Syndrome | Drug: RNF;Drug: Placebo | Merck KGaA | NULL | Completed | 18 Years | N/A | All | 402 | Phase 3 | Argentina;Austria;Belgium;Bulgaria;Canada;Croatia;Czech Republic;Estonia;Finland;France;Germany;Greece;Israel;Italy;Latvia;Lebanon;Morocco;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Saudi Arabia;Turkey |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1261 | NCT00811902 (ClinicalTrials.gov) | December 2008 | 18/12/2008 | Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients With Multiple Sclerosis. | Multiple Sclerosis | Drug: Nerispirdine (HP184);Drug: placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 405 | Phase 2 | United States;Canada;Finland;France;Germany;Norway;Spain |
| 1262 | EUCTR2008-002096-27-GB (EUCTR) | 28/11/2008 | 14/10/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United Kingdom;Austria;Poland;Lithuania | |||
| 1263 | EUCTR2006-001152-12-SK (EUCTR) | 11/11/2008 | 16/04/2008 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 1264 | EUCTR2007-007759-15-HU (EUCTR) | 10/11/2008 | 18/08/2008 | The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple SclerosisA double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trial | The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple SclerosisA double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trial | Patients with current diagnosis of SP-MS MedDRA version: 9.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: PI-2301 Product Code: CO-14 Other descriptive name: CO-14 | PEPTIMMUNE Inc | NULL | Not Recruiting | Female: yes Male: yes | 53 | Hungary | |||
| 1265 | NCT00753792 (ClinicalTrials.gov) | November 2008 | 16/9/2008 | Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse | Multicenter, Randomized, Double Blind, Clinical Trial to Compare the Clinical and Radiological Efficacy of Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During Relapse | Multiple Sclerosis | Drug: methylprednisolone;Drug: Placebo | Germans Trias i Pujol Hospital | NULL | Completed | 18 Years | 59 Years | Both | 49 | Phase 4 | Spain |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1266 | NCT00771043 (ClinicalTrials.gov) | November 2008 | 7/10/2008 | A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a | Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a | Relapsing-Remitting Multiple Sclerosis | Drug: TYSABRI and AVONEX | Biogen Idec | NULL | Withdrawn | 18 Years | 55 Years | Both | 50 | Phase 4 | United States |
| 1267 | EUCTR2007-002627-32-NL (EUCTR) | 31/10/2008 | 11/07/2008 | A clinical study in which the efficacy and safety of 0.5 mg FTY720 versus placebo is evaluated vluated in patients with primary progressive multiple sclerosis. | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | |||
| 1268 | EUCTR2007-001162-32-AT (EUCTR) | 23/10/2008 | 14/07/2008 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 573 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden | ||
| 1269 | EUCTR2007-001162-32-PL (EUCTR) | 21/10/2008 | 24/10/2008 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis. | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland | ||
| 1270 | EUCTR2007-001161-14-PL (EUCTR) | 21/10/2008 | 12/05/2008 | ?Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: MabCampath® INN or Proposed INN: Alemtuzumab Trade Name: Rebif Product Name: Rebif® INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1271 | EUCTR2007-004122-24-GB (EUCTR) | 14/10/2008 | 16/05/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 1272 | EUCTR2007-004452-36-CZ (EUCTR) | 13/10/2008 | 07/04/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;France;Australia;Netherlands;Tunisia;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | |||
| 1273 | EUCTR2007-006338-32-FI (EUCTR) | 08/10/2008 | 30/06/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy | ||
| 1274 | EUCTR2007-006338-32-BG (EUCTR) | 07/10/2008 | 31/07/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Multiple sclerosis is a disabling disease of brain and spinal cord thatdisrupts flow of information within brain, characterized by flare-ups withperiods of remission in between (relapsing remitting) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: oclelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 1275 | EUCTR2008-000499-25-SE (EUCTR) | 02/10/2008 | 16/05/2008 | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMS | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMS | Relapsing forms of Multiple Sclerosis (RMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Rebif New Formulation 44mcg multidose cartridge INN or Proposed INN: INTERFERON BETA-1A | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3b | Germany;Spain;Italy;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1276 | NCT00755807 (ClinicalTrials.gov) | October 2008 | 17/9/2008 | Duloxetine for Multiple Sclerosis Pain | Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis. | Multiple Sclerosis | Drug: Duloxetine Hydrochloride (HCI);Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 239 | Phase 3 | United States;Belgium;Canada;Poland |
| 1277 | NCT00784836 (ClinicalTrials.gov) | October 2008 | 29/10/2008 | Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients | A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: BG9418 (interferon beta 1-a) | Biogen | NULL | Terminated | 18 Years | 60 Years | All | 3 | Phase 3 | United States |
| 1278 | NCT01080027 (ClinicalTrials.gov) | October 2008 | 2/3/2010 | Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR) | An International, Multi Centre, Prospective, Observational Study of Safety, Tolerability and Adherence of Patients With Relapsing Remitting Multiple Sclerosis Administered Interferon Beta-1a (Rebif® New Formulation) in Real Life Settings | Multiple Sclerosis, Relapsing Remitting | Drug: Rebif® New Formulation | Merck KGaA | Merck A.E., Greece;Merck OY, Finland;Merck B.V., Netherlands;Merck A.B., Sweden;Merck, S.A., Portugal | Completed | 18 Years | 60 Years | Both | 254 | N/A | Greece |
| 1279 | NCT00780455 (ClinicalTrials.gov) | October 2008 | 28/5/2008 | Rehabilitation Study in MS Patients | Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon® | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b, FRP within 15 days after randomization;Drug: Interferon beta-1b, FRP about 6 weeks after randomization | Bayer | NULL | Terminated | 18 Years | N/A | All | 4 | Phase 4 | France |
| 1280 | EUCTR2007-004452-36-BE (EUCTR) | 30/09/2008 | 11/03/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;France;Australia;Netherlands;Tunisia;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1281 | EUCTR2006-006299-39-FR (EUCTR) | 24/09/2008 | 06/08/2007 | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | Patients with urinary incontinence due to neurogenic detrusor overactivity as a result of spinal cord injury or multiple sclerosis who have not been adequately managed with anticholinergic therapy and have neurological respiratory impairment. MedDRA version: 8.1;Level: LLT;Classification code 10046543;Term: Urinary incontinence | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum toxin type A Other descriptive name: Botulinum toxin type A | Allergan | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Netherlands;France | |||
| 1282 | EUCTR2006-001152-12-BG (EUCTR) | 17/09/2008 | 05/09/2008 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | ||
| 1283 | EUCTR2007-006338-32-BE (EUCTR) | 15/09/2008 | 17/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Netherlands;Germany;Serbia;United States;Slovakia;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria | ||
| 1284 | EUCTR2007-006338-32-IT (EUCTR) | 11/09/2008 | 02/10/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI. | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with RRMS. | Relapsing-Remitting Multiple Sclerosis (RRMS). MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Denmark;Bulgaria;Netherlands;Germany | ||
| 1285 | EUCTR2008-002096-27-PL (EUCTR) | 10/09/2008 | 25/06/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United Kingdom;Austria;Poland;Lithuania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1286 | EUCTR2008-002560-34-BE (EUCTR) | 02/09/2008 | 29/07/2008 | A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis - HMFR | A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis - HMFR | Central neuropathic pain due to Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain | Trade Name: Cymbalta Product Name: Duloxetine Product Code: LY248686 INN or Proposed INN: DULOXETINE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 238 | Belgium | |||
| 1287 | EUCTR2007-001377-28-DE (EUCTR) | 01/09/2008 | 15/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 1288 | NCT00772525 (ClinicalTrials.gov) | September 2008 | 13/10/2008 | Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis | A Double-blind, Placebo-controlled, Randomized Crossover, Activity Study of Single Oral Doses of 50 mg and 400 mg Nerispirdine on Visual Function in Patients With Multiple Sclerosis | Multiple Sclerosis;Optic Nerve;Neuritis | Drug: Nerispirdine (HP184);Drug: Placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 31 | Phase 2 | United States |
| 1289 | NCT01184833 (ClinicalTrials.gov) | September 2008 | 18/8/2010 | Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis | Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 852 | N/A | Poland |
| 1290 | EUCTR2006-003361-14-DK (EUCTR) | 29/08/2008 | 22/07/2008 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Estonia;Czech Republic;Finland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1291 | EUCTR2007-004122-24-FR (EUCTR) | 21/08/2008 | 03/06/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 1292 | EUCTR2007-001162-32-DK (EUCTR) | 20/08/2008 | 25/07/2008 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis. | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Belgium;Denmark;Argentina;Mexico;Spain;Croatia;United States;Poland | ||
| 1293 | EUCTR2007-004122-24-SK (EUCTR) | 18/08/2008 | 23/04/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 1294 | EUCTR2007-002627-32-BE (EUCTR) | 08/08/2008 | 20/08/2008 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delayingdisability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 1295 | EUCTR2007-001162-32-IT (EUCTR) | 06/08/2008 | 14/07/2008 | A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-II | A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MABCAMPATH INN or Proposed INN: Alemtuzumab Trade Name: REBIF INN or Proposed INN: Interferon beta-1a | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 573 | Phase 3 | France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1296 | EUCTR2007-002627-32-FR (EUCTR) | 05/08/2008 | 09/05/2008 | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | Primary progressive multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1297 | NCT00751881 (ClinicalTrials.gov) | August 2008 | 7/5/2008 | An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis | A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: Teriflunomide | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 1169 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Czech Republic;Estonia;France;Germany;Greece;Mexico;Netherlands;Philippines;Poland;Romania;Slovakia;Spain;Sweden;Thailand;Tunisia;Turkey;Ukraine;United Kingdom;South Africa |
| 1298 | NCT01074346 (ClinicalTrials.gov) | August 2008 | 22/2/2010 | Tolerability of Rebif® (Interferon-beta 1-A) Therapy in Korean Patients With Multiple Sclerosis | A Prospective, Multi-center, Observational Study to Assess the Tolerability of Interferon-beta 1-A (Rebif®) Therapy for Korean Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon-ß-1a | Merck KGaA | NULL | Completed | N/A | N/A | Both | 60 | N/A | Korea, Republic of |
| 1299 | EUCTR2008-000499-25-ES (EUCTR) | 31/07/2008 | 10/06/2008 | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS)Estudio de fase IIIb, de un solo brazo, abierto, 12 semanas de duración, multicéntrico e internacional, dirigido a evaluar la adecuación de RebiSmartTM para la autoinyección de Rebif® Nueva Formulación (RNF) en cartucho multidosis en pacientes con esclerosis múltiple recidivante (EMR) - RebiSmartTM in RMS | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS)Estudio de fase IIIb, de un solo brazo, abierto, 12 semanas de duración, multicéntrico e internacional, dirigido a evaluar la adecuación de RebiSmartTM para la autoinyección de Rebif® Nueva Formulación (RNF) en cartucho multidosis en pacientes con esclerosis múltiple recidivante (EMR) - RebiSmartTM in RMS | Relapsing forms of Multiple Sclerosis (RMS) Esclerosis múltiple recidivante (EMR) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Rebif New Formulation 44mcg multidose cartridge INN or Proposed INN: INTERFERON BETA-1A | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3b | Germany;Spain;Italy;Sweden | ||
| 1300 | NCT00676715 (ClinicalTrials.gov) | July 31, 2008 | 9/5/2008 | A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis | Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS | Multiple Sclerosis, Relapsing-Remitting | Drug: Placebo;Drug: Ocrelizumab;Drug: Avonex | Genentech, Inc. | Roche Pharma AG | Active, not recruiting | 18 Years | 55 Years | All | 220 | Phase 2 | United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Italy;Mexico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic;Finland;Netherlands |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1301 | EUCTR2007-001162-32-CZ (EUCTR) | 30/07/2008 | 31/03/2008 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 573 | Phase 3 | Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden | ||
| 1302 | EUCTR2007-006338-32-GB (EUCTR) | 28/07/2008 | 07/03/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 1303 | EUCTR2007-001162-32-SE (EUCTR) | 28/07/2008 | 28/12/2007 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis. | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland | ||
| 1304 | NCT00731692 (ClinicalTrials.gov) | July 28, 2008 | 7/8/2008 | This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS. | A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: FTY720;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 25 Years | 65 Years | All | 970 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Denmark;Finland;France;Germany;Hungary;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic |
| 1305 | EUCTR2008-000499-25-IT (EUCTR) | 24/07/2008 | 15/02/2010 | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmart suitability for selfinjection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmart in RMS | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmart suitability for selfinjection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmart in RMS | Relapsing forms of Multiple Sclerosis (RMS) MedDRA version: 9.1;Level: PT;Classification code 10063399 | INN or Proposed INN: Interferon beta-1a | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3b | Spain;Germany;Italy;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1306 | EUCTR2007-004452-36-DE (EUCTR) | 23/07/2008 | 07/05/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden | |||
| 1307 | EUCTR2007-004122-24-DE (EUCTR) | 22/07/2008 | 19/05/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | |||
| 1308 | EUCTR2007-006338-32-ES (EUCTR) | 16/07/2008 | 28/03/2008 | Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Esclerosis Múltiple Recurrente-remitente Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy | ||
| 1309 | EUCTR2007-001377-28-NL (EUCTR) | 15/07/2008 | 29/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 1310 | EUCTR2007-006338-32-DK (EUCTR) | 09/07/2008 | 09/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | Hoffman La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1311 | EUCTR2007-006338-32-DE (EUCTR) | 09/07/2008 | 17/03/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrrelizumab 300 mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrrelizumab 300 mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F. Hoffman-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 1312 | EUCTR2007-006338-32-NL (EUCTR) | 09/07/2008 | 29/05/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy | ||
| 1313 | EUCTR2007-003997-24-GB (EUCTR) | 08/07/2008 | 20/08/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 1314 | JPRN-UMIN000002725 | 2008/07/01 | 22/11/2009 | Efficacy of ramatroban in multiple sclerosis patients | Multiple sclerosis | Addition of ramatroban to conventional MS therapy | Iou hospital | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 5 | Not selected | Japan | |
| 1315 | NCT00735007 (ClinicalTrials.gov) | July 2008 | 12/8/2008 | 12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis. | International, Multicenter, Single-arm, Open-label, 12-week Phase IIIb Study to Evaluate RebiSmart™ Suitability for Self Injection of Rebif® New Formulation (RNF) in Multidose Cartridges in Patients With Relapsing Form of Multiple Sclerosis (RMS) | Multiple Sclerosis | Drug: Rebif® New Formulation (RNF) using RebiSmartTM | EMD Serono | NULL | Completed | 18 Years | 65 Years | All | 106 | Phase 3 | United States;Canada;Germany;Italy;Spain;Sweden |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1316 | NCT00674141 (ClinicalTrials.gov) | July 2008 | 6/5/2008 | Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment | Nasal Administration of Dexamethasone for MS Treatment | MS Patient With Relpasing Remitting Attacks | Drug: Dexamethasone soduim phosphate | Hadassah Medical Organization | NULL | Withdrawn | 18 Years | N/A | Both | 10 | Phase 1 | Israel |
| 1317 | NCT00726648 (ClinicalTrials.gov) | July 2008 | 29/7/2008 | CDP323 Biomarker Study | Double-blind, Placebo-controlled, Randomized, Parallel-group Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability. | Relapsing Multiple Sclerosis | Drug: CDP323;Drug: Placebo | UCB Pharma | Biogen Idec | Completed | 18 Years | 65 Years | Both | 71 | Phase 1;Phase 2 | United Kingdom |
| 1318 | EUCTR2007-001377-28-AT (EUCTR) | 26/06/2008 | 27/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 1319 | EUCTR2007-006338-32-SK (EUCTR) | 16/06/2008 | 09/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 1320 | EUCTR2007-002627-32-SE (EUCTR) | 12/06/2008 | 28/04/2008 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delayingdisability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - Efficacy and safety of 0.5 mg fingolimod in patients with PPMS | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Services Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1321 | EUCTR2007-001377-28-FR (EUCTR) | 11/06/2008 | 29/02/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 1322 | EUCTR2007-002627-32-IT (EUCTR) | 11/06/2008 | 16/05/2008 | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - ND | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - ND | primary progressive multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Product Name: fingolimod Product Code: FTY720D | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 650 | France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 1323 | EUCTR2007-004452-36-NL (EUCTR) | 09/06/2008 | 28/02/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;France;Australia;Tunisia;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | |||
| 1324 | EUCTR2007-002627-32-FI (EUCTR) | 05/06/2008 | 22/04/2008 | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 940 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 1325 | EUCTR2007-003997-24-IT (EUCTR) | 05/06/2008 | 13/06/2008 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-Aventis recherche & de'veloppement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1326 | EUCTR2007-001162-32-DE (EUCTR) | 02/06/2008 | 02/01/2008 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis. | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland | ||
| 1327 | EUCTR2007-004223-38-DE (EUCTR) | 02/06/2008 | 24/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Czech Republic;United Kingdom;Germany;Denmark;Sweden | |||
| 1328 | NCT00716066 (ClinicalTrials.gov) | June 2008 | 15/7/2008 | Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune Diseases | High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases | Autoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis Transplant;Autoimmune Nervous System Disorder;Central Nervous System Vasculitis;Cerebellar Degeneration;Chronic Inflammatory Demyelinating Polyneuropathy;Lambert Eaton Myasthenic Syndrome;Myasthenia Gravis;Neuromyelitis Optica;Opsoclonus Myoclonus Syndrome;Rasmussen Subacute Encephalitis | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow Transplantation | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Recruiting | N/A | 71 Years | All | 40 | Phase 2 | United States |
| 1329 | EUCTR2007-006338-32-CZ (EUCTR) | 28/05/2008 | 01/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 1330 | EUCTR2007-001162-32-BE (EUCTR) | 26/05/2008 | 22/01/2008 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 573 | Phase 3 | France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1331 | EUCTR2007-004452-36-EE (EUCTR) | 22/05/2008 | 09/04/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Czech Republic;Estonia;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | |||
| 1332 | EUCTR2007-001161-14-SE (EUCTR) | 21/05/2008 | 18/12/2007 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | Germany;France;Sweden;Australia;Brazil;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland | ||
| 1333 | EUCTR2007-005363-10-FR (EUCTR) | 13/05/2008 | 11/12/2007 | Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS | Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS | 1. Multiple Sclerosis2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis) MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive MedDRA version: 9.1;Classification code 10028246;Term: Multiple sclerosis aggravated MedDRA version: 9.1;Classification code 10028247;Term: Multiple sclerosis like syndrome MedDRA version: 9.1;Classification code 10028248;Term: Multiple sclerosis-like syndrome MedDRA version: 9.1;Classification code 10048393;Term: Multiple sclerosis relapse MedDRA version: 9.1;Classification code 10053395;Term: Progressive multiple sclerosis MedDRA version: 9.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis MedDRA version: 9.1;Classification code 10063401;Term: Primary progressive multiple sclerosis MedDRA version: 9.1;Classification code 10064137;Term: Progression of multiple sclerosis MedDRA version: 9.1;Level: PT;Term: Secondary progressive multiple sclerosis | Product Code: SH U 555 C | C.H.U. de RENNES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1334 | EUCTR2007-001162-32-NL (EUCTR) | 06/05/2008 | 19/12/2007 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden | ||
| 1335 | EUCTR2007-006338-32-FR (EUCTR) | 06/05/2008 | 26/02/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913/F03 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1336 | EUCTR2007-004223-38-SE (EUCTR) | 05/05/2008 | 13/03/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline AB | NULL | Not Recruiting | Female: yes Male: yes | 57 | Germany;Czech Republic;United Kingdom;Denmark;Sweden | |||
| 1337 | NCT00640328 (ClinicalTrials.gov) | May 2008 | 18/3/2008 | Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients | A Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) Patients | Multiple Sclerosis | Drug: Ofatumumab 100;Drug: Ofatumumab 300;Drug: Ofatumumab 700;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 38 | Phase 2 | Belgium;Czech Republic;Denmark;Former Serbia and Montenegro;Germany;Poland;Serbia;Sweden;United Kingdom |
| 1338 | EUCTR2007-004122-24-CZ (EUCTR) | 30/04/2008 | 03/01/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 1339 | EUCTR2006-006299-39-NL (EUCTR) | 23/04/2008 | 13/06/2007 | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | Patients with urinary incontinence due to neurogenic detrusor overactivity as a result of spinal cord injury or multiple sclerosis who have not been adequately managed with anticholinergic therapy and have neurological respiratory impairment. MedDRA version: 8.1;Level: LLT;Classification code 10046543;Term: Urinary incontinence | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum toxin type A Other descriptive name: Botulinum toxin type A | Allergan | NULL | Not Recruiting | Female: yes Male: yes | 135 | Netherlands;France | |||
| 1340 | EUCTR2008-001940-38-IT (EUCTR) | 22/04/2008 | 14/04/2008 | Functional RMN study to evaluate the prompt and middle term effect of the treatment with Donepezil in patients affected by multiple sclerosis and mild impairment of cognitive function. - ND | Functional RMN study to evaluate the prompt and middle term effect of the treatment with Donepezil in patients affected by multiple sclerosis and mild impairment of cognitive function. - ND | patients affected by multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: ARICEPT INN or Proposed INN: Donepezil Trade Name: ARICEPT INN or Proposed INN: Donepezil | OSPEDALE S. RAFFAELE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1341 | EUCTR2007-004223-38-BE (EUCTR) | 16/04/2008 | 06/05/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 324 | Sweden;Czech Republic;Belgium;Denmark;Germany;United Kingdom | |||
| 1342 | EUCTR2007-001161-14-FR (EUCTR) | 11/04/2008 | 08/01/2008 | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 525 | Phase 3 | Czech Republic;Germany;United Kingdom;France;Poland;Sweden | ||
| 1343 | EUCTR2007-001162-32-FR (EUCTR) | 11/04/2008 | 08/01/2008 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden | ||
| 1344 | EUCTR2007-001161-14-CZ (EUCTR) | 09/04/2008 | 11/09/2007 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Sclerosis. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif® INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | Germany;France;Australia;Brazil;Sweden;Czech Republic;Russian Federation;United Kingdom;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland | ||
| 1345 | EUCTR2007-003086-40-FR (EUCTR) | 08/04/2008 | 13/11/2007 | A Phase I/II Study of Pixantrone in Patients with an Aggressive Relapsing Remitting (RR) or Secondary Progressive (SP) Multiple Sclerosis (PIXAMS) | A Phase I/II Study of Pixantrone in Patients with an Aggressive Relapsing Remitting (RR) or Secondary Progressive (SP) Multiple Sclerosis (PIXAMS) | aggressive relapsing remitting (RR) or secondary progressive (SP) multiple sclerosis | Product Name: Pixantrone Product Code: BBR 2778 INN or Proposed INN: Pixantrone | Fondation Charcot Stichting | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | France | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1346 | EUCTR2007-004223-38-DK (EUCTR) | 04/04/2008 | 23/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 57 | Czech Republic;Denmark;Germany;United Kingdom;Sweden | |||
| 1347 | NCT00670449 (ClinicalTrials.gov) | April 2008 | 28/4/2008 | An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis | An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod | Novartis | Mitsubishi Tanabe Pharma Corporation | Completed | 18 Years | 60 Years | All | 143 | Phase 2 | Japan |
| 1348 | NCT00605215 (ClinicalTrials.gov) | April 2008 | 8/1/2008 | BRAVO Study: Laquinimod Double Blind Placebo Controlled Study in RRMS Patients With a Rater Blinded Reference Arm of Interferon ß-1a (Avonex®) | A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With RRMS to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and a Reference Arm of Interferon ß-1a (Avonex®) in a Rater-blinded Design. | Multiple Sclerosis | Drug: laquinimod;Drug: placebo;Drug: Interferon ß-1a (Avonex®) | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 55 Years | Both | 1331 | Phase 3 | United States;Bulgaria;Croatia;Czech Republic;Estonia;Georgia;Germany;Israel;Italy;Lithuania;Macedonia, The Former Yugoslav Republic of;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Latvia;Montenegro;Turkey |
| 1349 | EUCTR2007-004122-24-NL (EUCTR) | 26/03/2008 | 28/02/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 1350 | EUCTR2007-004122-24-BE (EUCTR) | 21/03/2008 | 13/02/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 0,5 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 0,5 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1351 | NCT00629642 (ClinicalTrials.gov) | March 14, 2008 | 26/2/2008 | Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis | A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With Neurogenic Detrusor Overactivity | Multiple Sclerosis;Neurogenic Bladder;Spinal Cord Diseases | Drug: Solifenacin Succinate;Drug: Oxybutynin Hydrochloride;Drug: Placebo | Astellas Pharma Inc | NULL | Completed | 18 Years | 65 Years | All | 249 | Phase 4 | Australia;Belgium;Czechia;France;Germany;Hungary;Italy;Netherlands;Russian Federation;Spain;United Kingdom;Czech Republic;Portugal |
| 1352 | EUCTR2007-000192-42-IT (EUCTR) | 10/03/2008 | 31/07/2007 | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - ND | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - ND | urinary incontinence caused by neurogenic detrusor overactivity (spinal lesion or multiple sclerosis) MedDRA version: 9.1;Level: LLT;Classification code 10029279;Term: Neurogenic bladder | Trade Name: BOTOX INN or Proposed INN: Botulinum toxin | ALLERGAN | NULL | Not Recruiting | Female: yes Male: yes | 260 | Portugal;United Kingdom;Germany;Netherlands;France;Spain;Italy | |||
| 1353 | EUCTR2006-003361-14-PT (EUCTR) | 07/03/2008 | 07/01/2008 | Multiple Sclerosis study to document the safety of two doses of teriflunomide | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1354 | EUCTR2007-002179-15-FR (EUCTR) | 04/03/2008 | 22/11/2007 | Etude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASH | Etude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASH | Méthylprednisolone administrée aux patients et contrôles à la dose de 1g/j pendant 3 jours, comme prescrit habituellement dans le cadre de leur pathologie. MedDRA version: 8.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1355 | NCT00429442 (ClinicalTrials.gov) | March 2008 | 30/1/2007 | Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis | A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in Patients Treated With Copaxone for at Least 3 Months | Relapsing Remitting Multiple Sclerosis | Drug: Simvastatin;Drug: placebo | Anna Tsakiri | Sanofi | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 3 | Denmark |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1356 | NCT00616733 (ClinicalTrials.gov) | March 2008 | 4/2/2008 | 12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients | An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: CS-0777 tablets | Daiichi Sankyo Inc. | NULL | Completed | 18 Years | 65 Years | Both | 25 | Phase 1 | United States |
| 1357 | EUCTR2007-004223-38-CZ (EUCTR) | 27/02/2008 | 02/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline s.r.o. | NULL | Not Recruiting | Female: yes Male: yes | 57 | Germany;United Kingdom;Czech Republic;Denmark;Sweden | |||
| 1358 | EUCTR2008-000490-37-IT (EUCTR) | 26/02/2008 | 20/03/2008 | Pharmacological treatment with memantine of oscilloscopy in patients suffering from multiple sclerosis: randomized,double blind placebo controlled study. - ND | Pharmacological treatment with memantine of oscilloscopy in patients suffering from multiple sclerosis: randomized,double blind placebo controlled study. - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028053;Term: MS | Trade Name: EBIXA INN or Proposed INN: Memantine | OSPEDALE S. RAFFAELE | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1359 | EUCTR2005-000365-19-GB (EUCTR) | 19/02/2008 | 11/11/2005 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - CFTY720D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - CFTY720D2301 | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | Estonia;Hungary;Czech Republic;Slovakia;Greece;Finland;Ireland;Lithuania;Germany;United Kingdom;Sweden | |||
| 1360 | EUCTR2006-003361-14-NL (EUCTR) | 12/02/2008 | 07/01/2008 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Norway;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1361 | EUCTR2006-001152-12-EE (EUCTR) | 08/02/2008 | 21/11/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 1362 | EUCTR2007-001161-14-DE (EUCTR) | 06/02/2008 | 23/08/2007 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland | ||
| 1363 | NCT00622700 (ClinicalTrials.gov) | February 2008 | 14/2/2008 | Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis | An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 618 | Phase 3 | United States;Australia;Austria;Bulgaria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Hungary;Lithuania;Mexico;Poland;Romania;Russian Federation;Turkey;Ukraine;United Kingdom;Brazil;Italy;Slovakia |
| 1364 | NCT00662649 (ClinicalTrials.gov) | February 2008 | 17/4/2008 | Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod 0.5 mg;Drug: Fingolimod 1.25 mg | Novartis | NULL | Completed | 20 Years | 58 Years | All | 920 | Phase 3 | Australia;Belgium;Canada;Czech Republic;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Netherlands;Poland;Romania;Russian Federation;Slovakia;South Africa;Sweden;Switzerland;Turkey;United Kingdom |
| 1365 | NCT00391352 (ClinicalTrials.gov) | February 2008 | 19/10/2006 | fMRI Study of Treatment Recommendations Comparing Recently Diagnosed Multiple Sclerosis (MS) Patients to Controls | A Phase 4, fMRI Study of Treatment Recommendations Comparing Patients Taking IFN-ß-1a 44 mcg Tiw SC (Rebif®) to Controls of Patients Recently Diagnosed With Relapsing Remitting Multiple Sclerosis Currently Naive to Disease-Modifying Therapy. | Relapsing-Remitting Multiple Sclerosis | Drug: IFN-ß-1a (Rebif®) | Waukesha Memorial Hospital | The Cleveland Clinic | Completed | 18 Years | 65 Years | Both | 21 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1366 | EUCTR2007-004122-24-SE (EUCTR) | 23/01/2008 | 19/12/2007 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 1367 | EUCTR2006-001152-12-HU (EUCTR) | 09/01/2008 | 09/10/2007 | Not applicable | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. - TOPIC | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 1368 | EUCTR2006-001152-12-FR (EUCTR) | 08/01/2008 | 11/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) - | Multiple Sclerosis | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 780 | Hungary;Finland;United Kingdom;Germany;Czech Republic;Denmark;Bulgaria;Estonia;France;Austria;Lithuania | ||||
| 1369 | NCT00464958 (ClinicalTrials.gov) | January 2008 | 22/4/2007 | One Year Extension Study To Protocol C2/5/TZ:MS-05 | Long Term Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in Patients With Multiple Sclerosis - Open Label Extension Study | Spasticity;Multiple Sclerosis | Drug: sublingual tizanidine 12 mg | Teva GTC | NULL | Terminated | 20 Years | 65 Years | Both | 10 | Phase 1;Phase 2 | Israel |
| 1370 | NCT00647348 (ClinicalTrials.gov) | January 2008 | 26/3/2008 | Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis | A Phase II Randomised, Placebo-controlled Clinical Trial of Simvastatin in Patients With Secondary Progressive Multiple Sclerosis. | Secondary Progressive Multiple Sclerosis | Drug: Simvastatin;Drug: Placebo | Imperial College London | NULL | Completed | 18 Years | 65 Years | All | 140 | Phase 2 | United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1371 | EUCTR2007-001162-32-GB (EUCTR) | 24/12/2007 | 04/10/2007 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 573 | Phase 3 | France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 1372 | EUCTR2007-005414-40-IT (EUCTR) | 21/12/2007 | 28/11/2007 | Efficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - ND | Efficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - ND | Patients with an established and stable Multiple Sclerosis (according to Poser criteria). MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: KEPPRA INN or Proposed INN: Levetiracetam | AZIENDA SANITARIA N. 3 GENOVESE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1373 | EUCTR2007-000586-38-IT (EUCTR) | 21/12/2007 | 10/01/2008 | HIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - ND | HIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - ND | PATIENTS AFFECTED BY MULTIPLE SCLEROSIS MedDRA version: 6.1;Level: HLT;Classification code 10052785 | Trade Name: THIOPLEX INN or Proposed INN: Thiotepa Trade Name: ENDOXAN BAXTER INN or Proposed INN: Cyclophosphamide Trade Name: NEUPOGEN INN or Proposed INN: Filgrastim | OSPEDALE S. RAFFAELE | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1374 | EUCTR2007-001958-99-FI (EUCTR) | 18/12/2007 | 07/12/2007 | Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS | Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS | Patients with relapsing remitting MS according to the revised Mc Donald's criteria who meet all criteria for inclusion and none criteria of exclusion. MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Dekristol 20000 IE Product Name: Dekristol INN or Proposed INN: INN COLECALCIFEROL Product Name: Placebo Dekristol SGC 20000 | Merja Soilu Häninen | NULL | Not Recruiting | Female: yes Male: yes | Finland | ||||
| 1375 | EUCTR2007-001962-34-DE (EUCTR) | 12/12/2007 | 05/11/2007 | Klassische Konditionierung immunologischer Reaktionen bei Patienten mit Multipler Sklerose während Mitoxantrontherapie - MIMIK | Klassische Konditionierung immunologischer Reaktionen bei Patienten mit Multipler Sklerose während Mitoxantrontherapie - MIMIK | secondary progressive multiple sclerosis | Trade Name: Ralenova INN or Proposed INN: mitoxantrone | University Medical Center Hamburg Eppendorf | NULL | Not Recruiting | Female: yes Male: yes | 5 | Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1376 | EUCTR2006-001152-12-DK (EUCTR) | 05/12/2007 | 30/10/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 1377 | NCT00573443 (ClinicalTrials.gov) | December 2007 | 13/12/2007 | Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) | Pseudobulbar Affect (PBA) | Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo | Avanir Pharmaceuticals | INC Research | Completed | 18 Years | 80 Years | All | 326 | Phase 3 | United States;Argentina;Brazil |
| 1378 | NCT00623415 (ClinicalTrials.gov) | December 2007 | 15/2/2008 | Flupirtine as Oral Treatment in Multiple Sclerosis | Multicentric, Prospective, Double Blind, Randomized/Stratified, Placebo-controlled Pilot-study for Evaluation of Safety and Efficacy of Flupirtine add-on to Interferon-ß1b on Neurodegeneration in Patients With Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Flupirtine;Drug: Placebo | Charite University, Berlin, Germany | Bayer | Terminated | 18 Years | 60 Years | All | 30 | Phase 2 | Germany |
| 1379 | EUCTR2007-003997-24-ES (EUCTR) | 26/11/2007 | 15/10/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias | Multiple Sclerosis.-----------------------Esclerosis Múltiple. | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 1380 | NCT00688948 (ClinicalTrials.gov) | November 2007 | 30/5/2008 | Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS) | A Pilot Study Looking At The Use Of Alfuzosin In The Treatment Of Bladder Dysfunction In Patients With Multiple Sclerosis | Multiple Sclerosis;Bladder Dysfunction | Drug: Alfuzosin | Capital District Health Authority, Canada | Sanofi | Terminated | 18 Years | N/A | Both | 20 | Phase 2;Phase 3 | Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1381 | NCT00937677 (ClinicalTrials.gov) | November 2007 | 9/7/2009 | Effect of Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis: A Follow-up Magnetization Transfer Imaging (MTI) Study | Effect of Natalizumab (Tysabri®) on Remyelination in Patients With Relapsing-remitting Multiple Sclerosis. A Follow-up Voxel-wise Magnetization Transfer Imaging Study. | Multiple Sclerosis | Drug: Tysabri | University at Buffalo | Biogen Idec | Completed | 18 Years | 65 Years | Both | 85 | N/A | United States |
| 1382 | EUCTR2006-001152-12-GB (EUCTR) | 24/10/2007 | 14/10/2010 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 1383 | EUCTR2006-001152-12-FI (EUCTR) | 15/10/2007 | 11/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | ||
| 1384 | EUCTR2006-001152-12-CZ (EUCTR) | 15/10/2007 | 07/08/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | ||
| 1385 | EUCTR2007-003997-24-AT (EUCTR) | 14/10/2007 | 21/09/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Multiple Sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1386 | EUCTR2006-001152-12-AT (EUCTR) | 04/10/2007 | 20/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 1387 | NCT00548405 (ClinicalTrials.gov) | October 2007 | 22/10/2007 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two | A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy | Multiple Sclerosis, Relapsing-Remitting | Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg;Biological: Interferon beta-1a | Genzyme, a Sanofi Company | Bayer | Completed | 18 Years | 55 Years | All | 840 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czech Republic;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom |
| 1388 | NCT00811395 (ClinicalTrials.gov) | October 2007 | 18/12/2008 | Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis | Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-ß [IFN-ß];Drug: Glatiramer Acetate [GA] | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 182 | Phase 2 | United States;Austria;Canada;Germany;Italy;Spain;United Kingdom |
| 1389 | NCT00873340 (ClinicalTrials.gov) | October 2007 | 31/3/2009 | Physical Disability in Patients Treated With Betaferon | Physical Disability Observational Study in Patients Treated With Betaferon in Daily Practice | Multiple Sclerosis | Drug: Interferon-1beta (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 83 | N/A | Colombia |
| 1390 | NCT00104143 (ClinicalTrials.gov) | October 2007 | 23/2/2005 | A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis. | A Randomized, Double-blind, Placebo Controlled Dose-ranging Study to Determine the Effect on MRI Lesions and Safety of A4I Antagonist in Relapsing Multiple Sclerosis. | Multiple Sclerosis | Drug: A4I Antagonist | Hoffmann-La Roche | NULL | Withdrawn | 18 Years | 59 Years | Both | 0 | Phase 2 | Bulgaria;Canada;Czech Republic;Germany;Poland;Russian Federation;Slovakia;Spain;United Kingdom;Finland;United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1391 | EUCTR2006-001337-17-DE (EUCTR) | 25/09/2007 | 26/03/2007 | Characterisation of multiple sclerosis pathology by ultra small particles of iron oxide (USPIO)” in comparison with conventional and advanced MRI imaging techniques[Charakterisierung der Multiple Sklerose Pathologie durch ultra small particles of iron oxide (USPIO)” im Vergleich zu konventionellen und fortgeschrittenen MRT Techniken] - MS_USPIO_MPIP | Characterisation of multiple sclerosis pathology by ultra small particles of iron oxide (USPIO)” in comparison with conventional and advanced MRI imaging techniques[Charakterisierung der Multiple Sklerose Pathologie durch ultra small particles of iron oxide (USPIO)” im Vergleich zu konventionellen und fortgeschrittenen MRT Techniken] - MS_USPIO_MPIP | Patients with Multiple Sclerosis (MS, N=90) and patients with a clinically isolated syndrome (ref. to as CIS in literature, i. e. not a clinically definite MS but a syndrome that may occur as first sign of MS early in the course, N=15) are planned to be investigated in the proposed clinical trial. MedDRA version: 8.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: ultra small particles of iron oxide (USPIO) Product Code: SH U 555 C INN or Proposed INN: SH U 555 C Other descriptive name: Ultrasmall particles of iron oxide | Max-Planck-Institute of Psychiatry | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 1392 | EUCTR2006-006347-31-GB (EUCTR) | 06/09/2007 | 07/08/2007 | A Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosis | A Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosis | Multiple Sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | United Kingdom | |||
| 1393 | NCT00537082 (ClinicalTrials.gov) | September 2007 | 26/9/2007 | Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS) | A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: FTY720;Drug: Placebo | Novartis | Mitsubishi Tanabe Pharma Corporation | Completed | 18 Years | 60 Years | All | 171 | Phase 2 | Japan |
| 1394 | NCT00638833 (ClinicalTrials.gov) | September 2007 | 12/3/2008 | Memantine Therapy for Multiple Sclerosis | Pilot Clinical Trial With Memantine for Cognitive Deficits in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Memantine;Drug: Placebo | Clinica Universidad de Navarra, Universidad de Navarra | H. Lundbeck A/S | Terminated | 18 Years | 65 Years | Both | 20 | Phase 2 | Spain |
| 1395 | NCT00544037 (ClinicalTrials.gov) | September 2007 | 15/10/2007 | BENEFIT Extension Study | Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 23 Years | 50 Years | Both | 283 | N/A | Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Slovenia;Spain;Sweden;Switzerland;Portugal;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1396 | NCT00937157 (ClinicalTrials.gov) | September 2007 | 9/7/2009 | Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA) | Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI Study | Multiple Sclerosis | Drug: Copaxone | University at Buffalo | Teva Neuroscience, Inc. | Completed | 18 Years | 65 Years | All | 12 | N/A | United States |
| 1397 | NCT00532532 (ClinicalTrials.gov) | September 2007 | 18/9/2007 | Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis | AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis | Muscle Spasticity | Drug: tolperisone HCl | Avigen | NULL | Terminated | 18 Years | 70 Years | Both | 150 | Phase 2 | Czech Republic;Germany;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro |
| 1398 | EUCTR2007-001161-14-GB (EUCTR) | 24/08/2007 | 01/08/2007 | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | Czech Republic;Germany;United Kingdom;France;Poland;Sweden | ||
| 1399 | NCT00649792 (ClinicalTrials.gov) | August 2007 | 28/3/2008 | Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial | Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial | Multiple Sclerosis | Drug: Fampridine-SR | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 214 | Phase 3 | United States;Canada |
| 1400 | NCT01235455 (ClinicalTrials.gov) | August 2007 | 4/11/2010 | Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectors | Portuguese BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis (MS) After Conversion to Betaferon by Using Elements of the BetaPlus Program | Relapsing Remitting Multiple Sclerosis (RRMS);Secondary Progressive Multiple Sclerosis (SPMS) | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 10 | N/A | Portugal |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1401 | NCT00530348 (ClinicalTrials.gov) | August 2007 | 13/9/2007 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: Alemtuzumab;Biological: Interferon beta-1a | Genzyme, a Sanofi Company | Bayer | Completed | 18 Years | 50 Years | All | 581 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;Croatia;Czech Republic;France;Germany;Mexico;Poland;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom;Former Serbia and Montenegro |
| 1402 | EUCTR2006-003361-14-SE (EUCTR) | 24/07/2007 | 27/06/2007 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1403 | EUCTR2006-005270-47-GR (EUCTR) | 03/07/2007 | 18/06/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3b | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1404 | NCT00469378 (ClinicalTrials.gov) | July 2007 | 2/5/2007 | Study Of White Blood Cells In The Cerebrospinal Fluid And Blood Of Patients With Relapsing Forms Of Multiple Sclerosis | An Open-label Study of Leukocyte Counts in the Cerebrospinal Fluid and Blood of Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment With Firategrast | Multiple Sclerosis | Drug: firategrast | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 46 | Phase 2 | Belgium;Czech Republic;Denmark;Norway;Sweden |
| 1405 | EUCTR2006-005270-47-IT (EUCTR) | 28/06/2007 | 19/07/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other- day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind betaseron/Betaferon 250 ?g or 500 ?g or open-label Betaseron/Betaferon 250 ?g and (Phase B) open-label Betaseron/Betaferon 500 ?g - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other- day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind betaseron/Betaferon 250 ?g or 500 ?g or open-label Betaseron/Betaferon 250 ?g and (Phase B) open-label Betaseron/Betaferon 500 ?g - Beyond Follow-up | Relapsing multiple sclerosis MedDRA version: 6.1;Level: PT;Classification code 10028245 | Trade Name: BETAFERON 250 mcg INN or Proposed INN: interferon beta-1b Product Name: BETAFERON 500 mcg Product Code: ZK 157046 INN or Proposed INN: interferon beta-1b | SCHERING | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3b | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1406 | NCT00959218 (ClinicalTrials.gov) | June 2007 | 13/8/2009 | Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis | Multi-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic Pain | Central Neuropathic Pain in Multiple Sclerosis | Drug: Dronabinol;Drug: Placebo | Bionorica Research GmbH | NULL | Completed | 18 Years | 70 Years | Both | 240 | Phase 3 | Germany |
| 1407 | EUCTR2006-003361-14-IT (EUCTR) | 23/05/2007 | 07/03/2007 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D Product Name: teriflunomide Product Code: HMR1726D | sanofi-aventis recherche de veloppement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 1408 | EUCTR2006-005270-47-FR (EUCTR) | 22/05/2007 | 23/01/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1880 | Phase 3b | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1409 | EUCTR2006-005270-47-SI (EUCTR) | 16/05/2007 | 04/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3b | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1410 | EUCTR2005-000365-19-LT (EUCTR) | 11/05/2007 | 27/03/2007 | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720 Product Name: FTY720 Product Code: FTY720 | NovartisPharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Sweden;Lithuania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1411 | EUCTR2006-005270-47-LV (EUCTR) | 02/05/2007 | 03/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3b | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1412 | NCT00483652 (ClinicalTrials.gov) | May 2007 | 6/6/2007 | Study of Fampridine-SR Tablets in Multiple Sclerosis Patients | Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR (10 mg b.i.d. [Bis in Die, Twice Daily]) in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Fampridine-SR;Drug: Placebo | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 240 | Phase 3 | United States;Canada |
| 1413 | NCT00459667 (ClinicalTrials.gov) | May 2007 | 11/4/2007 | BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose | International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 55 Years | All | 1420 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine |
| 1414 | NCT00928967 (ClinicalTrials.gov) | May 2007 | 23/6/2009 | Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients | Prospective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMS | Multiple Sclerosis | Drug: Interferon beta-1b, (Betaseron BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 67 | N/A | France |
| 1415 | NCT00461396 (ClinicalTrials.gov) | May 2007 | 17/4/2007 | Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron | Open-Label, Multicenter, Observational, Phase IV Study to Evaluate the Adherence to Treatment With 250mcg (8MIU) IFNB-1b (Betaseron®) Given Subcutaneous Every Other Day Over a Period of up to 12 Months in Patients With a First Clinical Demyelinating Event Suggestive of Multiple Sclerosis and Patients With Onset of Relapsing-Remitting Multiple Sclerosis (RRMS) Within the Past 12 Months | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon-1beta (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 50 Years | Both | 104 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1416 | EUCTR2005-000365-19-EE (EUCTR) | 26/04/2007 | 01/03/2007 | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | Remitting-relapsing Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720 Product Name: FTY720 Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1417 | EUCTR2006-000704-17-BE (EUCTR) | 25/04/2007 | 06/07/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: Fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Portugal;Hungary;Greece;Spain;Belgium;Austria;Germany;Italy;United Kingdom | |||
| 1418 | EUCTR2008-000955-90-IT (EUCTR) | 24/04/2007 | 12/03/2008 | Randomized, single-blind, clinical and MRI study for evaluation of safety and efficacy of N-Acetyl Cysteine (NAC) associated with high-dose beta-Interferon in Relapsing-Remitting (RR) multiple sclerosis patients - renac | Randomized, single-blind, clinical and MRI study for evaluation of safety and efficacy of N-Acetyl Cysteine (NAC) associated with high-dose beta-Interferon in Relapsing-Remitting (RR) multiple sclerosis patients - renac | multiple sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive | Product Name: n-acetylcysteine INN or Proposed INN: Acetylcysteine | ISTITUTO C. MONDINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1419 | EUCTR2006-005270-47-FI (EUCTR) | 23/04/2007 | 19/12/2006 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | |||
| 1420 | NCT00548769 (ClinicalTrials.gov) | April 21, 2007 | 23/10/2007 | Firategrast (SB683699) Surface Area Study in Multiple Sclerosis Patients | An Open-label, Randomised, Four Period Crossover Study to Investigate the Relative Pharmacokinetic Profiles of Tablets From Three Batches of Firategrast With Different Surface Areas and Two Different Tablet Formulations Containing the Same Batch of Firategrast, Given as Single 900mg Doses to Male and Female Subjects With a Diagnosis of Multiple Sclerosis | Multiple Sclerosis | Drug: Formulation A;Drug: Formulation B;Drug: Formulation C;Drug: Formulation D | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 37 | Phase 1 | Czechia;Germany;Poland;Czech Republic |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1421 | EUCTR2006-000704-17-HU (EUCTR) | 16/04/2007 | 27/07/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria | |||
| 1422 | EUCTR2006-005270-47-HU (EUCTR) | 16/04/2007 | 09/03/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3b | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1423 | EUCTR2006-005270-47-BE (EUCTR) | 12/04/2007 | 22/12/2006 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3b | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 1424 | EUCTR2006-005270-47-ES (EUCTR) | 08/04/2007 | 05/02/2007 | Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up | Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up | Esclerosis Múltiple Recidivante | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | |||
| 1425 | EUCTR2006-005270-47-NL (EUCTR) | 02/04/2007 | 18/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3b | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1426 | EUCTR2005-000365-19-IE (EUCTR) | 30/03/2007 | 18/01/2007 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1427 | EUCTR2005-000365-19-GR (EUCTR) | 13/03/2007 | 02/10/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1428 | EUCTR2006-004736-79-CZ (EUCTR) | 06/03/2007 | 17/10/2006 | A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis. | A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis. | To evaluate the efficacy of a selected treatment regimen of ATL 1102 in patients with Relapsing Remitting MS (RRMS) inflammatory lesions using MRI with gadolinium administration compared to placebo. | Product Name: ATL1102 Product Code: ATL1102 | Antisense Therapeutics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Czech Republic | |||
| 1429 | EUCTR2006-003361-14-DE (EUCTR) | 01/03/2007 | 28/12/2006 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United States;Portugal;Estonia;Finland;Ukraine;Austria;Chile;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Sweden | |||
| 1430 | NCT01111656 (ClinicalTrials.gov) | March 2007 | 15/3/2010 | Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b | SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study (SWABIMS Follow Up-study) | Relapsing-remitting Multiple Sclerosis | Drug: Interferon beta-1b group;Drug: Interferon beta-1b/Atorvastatin group | University Hospital Inselspital, Berne | Viollier AG, Basel, Switzerland;PharmaPart GmbH, Thalwil, Switzerland | Completed | 18 Years | 67 Years | Both | 28 | Phase 2 | Switzerland |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1431 | EUCTR2006-005270-47-SE (EUCTR) | 28/02/2007 | 02/02/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer AB, Bayer Health Care, Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3b | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1432 | EUCTR2006-005270-47-AT (EUCTR) | 22/02/2007 | 31/01/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3b | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Germany;Latvia;Netherlands;Sweden | ||
| 1433 | EUCTR2006-002856-14-DE (EUCTR) | 21/02/2007 | 07/11/2006 | Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis. | Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis. | Secondary progressive or progressive relapsing multiple sclerosis with signs of disease activity in terms of inflammation MedDRA version: 8.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Trade Name: Ovastat 1000 INN or Proposed INN: TREOSULFAN Trade Name: Ovastat 5000 INN or Proposed INN: TREOSULFAN | medac Gesellschaft für klinische Spezialpräparate mbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | |||
| 1434 | EUCTR2007-000503-15-IT (EUCTR) | 19/02/2007 | 20/04/2007 | Experimental clinical open study, randomized, experimental group vs control group, for the evaluation of tolerability and the effects on magnetic resonance parameters and cognitive functions of memantine in patients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta. - NEMESI-MS Neuroprotection by Memantine at Early Stage In Multiple Sclerosis | Experimental clinical open study, randomized, experimental group vs control group, for the evaluation of tolerability and the effects on magnetic resonance parameters and cognitive functions of memantine in patients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta. - NEMESI-MS Neuroprotection by Memantine at Early Stage In Multiple Sclerosis | patients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta. MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: EBIXA INN or Proposed INN: Memantine | AZ. OSPEDALIERA GARIBALDI, S.LUIGI CURRO , ASCOLI TOMASELLI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1435 | EUCTR2006-005270-47-IE (EUCTR) | 16/02/2007 | 10/01/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - Beyond Follow-up | Relapsing Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Betaferon 250mcg Product Name: Betaferon 500mcg Product Code: ZK 157046 | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3b | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1436 | NCT00870155 (ClinicalTrials.gov) | February 2007 | 26/3/2009 | A Study for Patients With Multiple Sclerosis | An Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Drug: dirucotide | Eli Lilly and Company | BioMS Technology Corp. | Terminated | 18 Years | 65 Years | Both | 546 | Phase 2;Phase 3 | Canada;Denmark;Estonia;Finland;Germany;Latvia;Netherlands;Spain;Sweden;United Kingdom |
| 1437 | NCT00845338 (ClinicalTrials.gov) | February 2007 | 16/2/2009 | Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity | A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity | Multiple Sclerosis;Overactive Detrusor | Drug: Darifenacin (BAY79-4998) | Bayer | NULL | Terminated | 18 Years | N/A | Both | 7 | Phase 2 | Germany |
| 1438 | EUCTR2005-000365-19-HU (EUCTR) | 25/01/2007 | 22/09/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Finland;Hungary;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1439 | EUCTR2006-003361-14-GB (EUCTR) | 23/01/2007 | 29/09/2006 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 1440 | EUCTR2006-004736-79-SK (EUCTR) | 19/01/2007 | 17/10/2006 | A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis. | A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis. | To evaluate the efficacy of a selected treatment regimen of ATL 1102 in patients with Relapsing Remitting MS (RRMS) inflammatory lesions using MRI with gadolinium administration compared to placebo. | Product Name: ATL1102 Product Code: ATL1102 | Antisense Therapeutics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Slovakia | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1441 | EUCTR2006-004255-38-DE (EUCTR) | 17/01/2007 | 20/02/2007 | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Patients with multiple sclerosis associated with central neuropathic pain MedDRA version: 8.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain | Product Name: dronabinol Product Code: cnp-MS-0601 INN or Proposed INN: dronabinol Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol | Bionorica research GmbH | NULL | Not Recruiting | Female: yes Male: yes | 240 | Austria;Germany | |||
| 1442 | EUCTR2006-004255-38-DK (EUCTR) | 15/01/2007 | 18/12/2006 | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central pain | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central pain | Patients with multiple sclerosis associated with central neuropathic pain MedDRA version: 8.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain | Product Name: dronabinol Product Code: cnp-MS-0601 INN or Proposed INN: dronabinol Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol | Bionorica research GmbH | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Austria;Denmark;Germany | ||
| 1443 | EUCTR2006-004255-38-AT (EUCTR) | 05/01/2007 | 06/11/2006 | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Patients with multiple sclerosis associated with central neuropathic pain MedDRA version: 16.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852 | Product Name: dronabinol Product Code: cnp-MS-0601 INN or Proposed INN: dronabinol Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol | Bionorica research GmbH | NULL | Not Recruiting | Female: yes Male: yes | 240 | Austria;Germany | |||
| 1444 | NCT00414453 (ClinicalTrials.gov) | January 2007 | 19/12/2006 | Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis | Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS) | Neuropathic Pain;Chronic Pain;Multiple Sclerosis | Drug: Lidocaine patch 5%;Drug: Extended-release oxycodone;Drug: Placebo extended-release oxycodone pills;Drug: Placebo lidocaine patches | University of Rochester | Endo Pharmaceuticals | Terminated | 18 Years | N/A | All | 19 | Phase 4 | United States |
| 1445 | EUCTR2006-003361-14-FI (EUCTR) | 19/12/2006 | 10/11/2006 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1446 | EUCTR2006-000704-17-GR (EUCTR) | 19/12/2006 | 11/08/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: Fingolimod Product Name: Interferon beta-1a INN or Proposed INN: interferon beta-1a | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1275 | Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria | |||
| 1447 | EUCTR2006-002361-39-DE (EUCTR) | 01/12/2006 | 21/08/2006 | A 4-week, open-label, multicenter, urodynamic pilot study to explore the efficacy, tolerability and safety of darifenacin (7.5 mg with up-titration to 15 mg) in patients with multiple sclerosis and neurogenic detrusor overactivity | A 4-week, open-label, multicenter, urodynamic pilot study to explore the efficacy, tolerability and safety of darifenacin (7.5 mg with up-titration to 15 mg) in patients with multiple sclerosis and neurogenic detrusor overactivity | Neurogenic overactive bladder disaese in patients with multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10059617;Term: Overactive bladder | Trade Name: EMSELEX 7,5 mg Retardtabletten Product Name: Darifenacin Product Code: BAY 79-4998 INN or Proposed INN: Darifenacin Trade Name: EMSELEX 15 mg Retardtabletten Product Name: Darifenacin Product Code: BAY 79-4998 INN or Proposed INN: Darifenacin | Bayer Vital GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 1448 | NCT00358293 (ClinicalTrials.gov) | December 2006 | 27/7/2006 | Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant Spasticity | A Double-Blind, Randomized, Crossover Study to Evaluate the Clinical Efficacy and Safety of Oral Tizanidine HCl (12 mg) Versus Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in MS Patients | Muscle Spasticity | Drug: Tizanidine (sublingual or oral) | Teva GTC | NULL | Completed | 20 Years | 65 Years | Both | 20 | Phase 1;Phase 2 | Israel |
| 1449 | NCT00594087 (ClinicalTrials.gov) | December 2006 | 3/1/2008 | Eszopiclone for Improving Sleep in Multiple Sclerosis (MS) | Eszopiclone for Improving Sleep Continuity in MS Patients With Sleep Disturbances and Its Impact on Daytime Fatigue | Relapsing Remitting Multiple Sclerosis;Sleep Initiation and Maintenance Disorders;Fatigue | Drug: eszopiclone;Other: placebo | University of Vermont | NULL | Completed | 18 Years | 64 Years | Both | 30 | N/A | United States |
| 1450 | EUCTR2006-003361-14-AT (EUCTR) | 21/11/2006 | 10/10/2006 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United States;Portugal;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Norway;Germany;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1451 | EUCTR2006-000704-17-PT (EUCTR) | 09/11/2006 | 02/08/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional extension phase - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional extension phase - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Trade Name: Avonex Product Name: Interferon beta-1a INN or Proposed INN: interferon beta-1a | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Phase - | Hungary;Portugal;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria | ||
| 1452 | NCT00869986 (ClinicalTrials.gov) | November 2006 | 24/3/2009 | A Study for Patients With Relapsing Remitting Multiple Sclerosis | A Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: dirucotide;Drug: placebo | Eli Lilly and Company | BioMS Technology Corp. | Completed | 18 Years | 50 Years | Both | 218 | Phase 2;Phase 3 | Bulgaria;Poland;Russian Federation;Serbia;Slovakia;Ukraine |
| 1453 | NCT00370071 (ClinicalTrials.gov) | November 2006 | 29/8/2006 | Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis | Open Label Study to Evaluate the Effect, Safety and Tolerability of 250µg (8 MIU) Interferon Beta 1b (Betaferon) Given Subcutaneously Every Other Day (for 24 Weeks) in Patients of Chinese Origin With Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 16 Years | 55 Years | All | 39 | Phase 3 | China |
| 1454 | EUCTR2006-000704-17-GB (EUCTR) | 19/10/2006 | 10/05/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: Fingolimod Product Name: Interferon beta-1a INN or Proposed INN: interferon beta-1a Product Code: FTY720 INN or Proposed INN: Fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Phase - | Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria | ||
| 1455 | EUCTR2004-002567-24-GB (EUCTR) | 09/10/2006 | 22/02/2005 | A Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicable | A Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicable | The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS). MedDRA version: 8.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: MLN1202 Product Code: MLN1202 | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Czech Republic;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1456 | NCT00803049 (ClinicalTrials.gov) | October 2006 | 1/12/2008 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide (HMR1726) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 742 | Phase 3 | United States;Austria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 1457 | EUCTR2005-005985-35-CZ (EUCTR) | 22/09/2006 | 02/08/2006 | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. | Relapsing forms of Multiple Sclerosis MedDRA version: 8.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BIRT 2584 XX Product Code: BIRT 2584 XX | Boehringer Ingelheim Ltd | NULL | Not Recruiting | Female: yes Male: yes | 320 | Czech Republic;Netherlands;Italy | |||
| 1458 | EUCTR2006-000704-17-IT (EUCTR) | 15/09/2006 | 06/11/2009 | A 12-month double-blind, randomized, multicenter, active-controlled, parallel-group study comparing the efficacy and safety of two doses of fingolimod FTY720 0.5 mg and 1.25 mg administered orally once daily versus interferon beta-1a Avonex administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | A 12-month double-blind, randomized, multicenter, active-controlled, parallel-group study comparing the efficacy and safety of two doses of fingolimod FTY720 0.5 mg and 1.25 mg administered orally once daily versus interferon beta-1a Avonex administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | Relapsing-remitting multiple sclerosis MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: fingolimod Product Code: FTY720D Product Name: fingolimod Product Code: FTY720D INN or Proposed INN: Interferon beta-1a | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria | |||
| 1459 | EUCTR2006-000704-17-AT (EUCTR) | 08/09/2006 | 12/07/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: Fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria | |||
| 1460 | EUCTR2004-001286-17-PT (EUCTR) | 08/09/2006 | 23/03/2006 | Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis | Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis | Relapsing-remitting or relapsing secondary progressive multiple sclerosis with high activity MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Mitoxantrone Product Code: N/A | Fundación Española de Esclerosis Múltiple (FEDEM) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Portugal | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1461 | EUCTR2005-005751-18-GB (EUCTR) | 07/09/2006 | 17/02/2006 | A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study | A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study | Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK. | Trade Name: Rebif 44 Product Name: Rebif 44 Product Code: Interferon beta 1a INN or Proposed INN: Interferon beta 1a Trade Name: Rebif 22 Product Name: Rebif 22 Product Code: Interferon beta 1a INN or Proposed INN: Interferon beta 1a Product Name: Betaferon 500mcg Product Code: Betaferon 500mcg INN or Proposed INN: Interferon beta 1b | UCL Biomedicine R&D Unit | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom | |||
| 1462 | EUCTR2005-005985-35-IT (EUCTR) | 05/09/2006 | 15/01/2007 | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. - ND | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. - ND | relapsing forms of multiple sclerosis MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Code: BIRT 2584XX Product Code: BIRT 2584 XX | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Czech Republic;Netherlands;Italy | |||
| 1463 | NCT00398528 (ClinicalTrials.gov) | September 2006 | 9/11/2006 | An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis | An fMRI Study of Treatment Optimization Recommendations Comparing Patients Changing Treatment From Glatiramer Acetate 20 mg qd SC (Copaxone®) to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Those Changing From to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Glatiramer Acetate 20 mg qd SC (Copaxone®) in a Multicenter Study of Patients With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying Therapy. | Relapsing-Remitting Multiple Sclerosis | Drug: Glatiramer acetate, (Copaxone®);Drug: IFN-ß-1a, (Avonex®) | Neurognostics | NULL | Terminated | 18 Years | 65 Years | Both | 48 | United States | |
| 1464 | NCT00261326 (ClinicalTrials.gov) | September 2006 | 2/12/2005 | Simvastatin Treatment of Patients With Acute Optic Neuritis | Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial | Optic Neuritis;Multiple Sclerosis | Drug: simvastatin;Drug: placebo | Glostrup University Hospital, Copenhagen | Alpharma ApS | Active, not recruiting | 18 Years | 59 Years | Both | 64 | Phase 3 | Denmark |
| 1465 | NCT00381264 (ClinicalTrials.gov) | September 2006 | 25/9/2006 | Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple Sclerosis | A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Cesamet™ (nabilone) | NEMA Research, Inc. | NULL | Completed | 18 Years | 75 Years | Both | 23 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1466 | NCT00588393 (ClinicalTrials.gov) | September 2006 | 22/12/2007 | FolateScan in Autoimmune Disease | Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases | Rheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus Erythematosus | Drug: FolateScan (Technetium Tc 99mEC20) | Mayo Clinic | Endocyte | Completed | 18 Years | N/A | Both | 75 | Phase 2 | United States |
| 1467 | EUCTR2005-005985-35-NL (EUCTR) | 29/08/2006 | 05/07/2006 | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. | Relapsing forms of Multiple Sclerosis MedDRA version: 8.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BIRT 2584 XX Product Code: BIRT 2584 XX | Boehringer Ingelheim | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Czech Republic;Netherlands;Italy | |||
| 1468 | EUCTR2006-000704-17-DE (EUCTR) | 21/08/2006 | 12/06/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: Fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Phase - | Portugal;Hungary;United Kingdom;Germany;Belgium;Spain;Italy;Greece;Austria | ||
| 1469 | EUCTR2006-004937-13-IT (EUCTR) | 17/08/2006 | 04/07/2007 | multicentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trial | multicentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trial | patients with relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: AZATIOPRINA HEX. 50CPR 50MG BL INN or Proposed INN: Azathioprine Trade Name: REBIF SC 12SIR 6000000UI 22MCG INN or Proposed INN: Interferon beta-1a Trade Name: BETAFERON SC 15F 0,25MG 15SIR INN or Proposed INN: Interferon beta-1b Trade Name: REBIF SC 12SIR 12000000UI44MCG INN or Proposed INN: Interferon beta-1a Trade Name: AVONEX IM 4SIR 30MCG/0,5ML 4AG INN or Proposed INN: Interferon beta-1a | Universita di Firenze | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1470 | EUCTR2005-000365-19-FI (EUCTR) | 14/07/2006 | 16/06/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1471 | EUCTR2006-002037-20-IT (EUCTR) | 12/07/2006 | 30/08/2006 | A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTE | A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTE | Patients with Relapsing - Remitting Multiple Sclerosis. MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: 40 mg Glatiramer acetato Product Code: 40 mg GA INN or Proposed INN: Glatiramer acetate Trade Name: COPAXONE*SC 28SIR 20MG/ML INN or Proposed INN: Glatiramer acetate | Teva Pharmaceuticals Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1472 | NCT00644904 (ClinicalTrials.gov) | July 2006 | 24/3/2008 | Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis | A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis | Multiple Sclerosis | Dietary Supplement: Vitamin D3 | University of Toronto | Direct MS-Proactive Charity;Multiple Sclerosis Society of Canada | Completed | 18 Years | 55 Years | Both | 49 | Phase 1;Phase 2 | Canada |
| 1473 | NCT00501943 (ClinicalTrials.gov) | July 2006 | 12/7/2007 | Neuroprotection With Riluzole Patients With Early Multiple Sclerosis | Neuroprotection With Riluzole in Patients With Early Multiple Sclerosis | Multiple Sclerosis | Drug: Avonex (Interferon beta 1a);Drug: Riluzole;Drug: Placebo | University of California, San Francisco | National Multiple Sclerosis Society;Oregon Health and Science University | Completed | 18 Years | 55 Years | All | 43 | Phase 2 | United States |
| 1474 | NCT00638027 (ClinicalTrials.gov) | July 2006 | 10/3/2008 | Memantine for Spasticity in MS Patients | Memantine for Spasticity in MS Patients | Multiple Sclerosis | Drug: placebo;Drug: memantine | University of Rochester | Forest Laboratories | Completed | 18 Years | 70 Years | All | 21 | Phase 4 | United States |
| 1475 | EUCTR2005-005679-13-IT (EUCTR) | 28/06/2006 | 23/06/2006 | An open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis. - ND | An open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis. - ND | multiple sclerosis MedDRA version: 6.1;Level: PT;Classification code 10053395 | INN or Proposed INN: Naltrexone | OSPEDALE S. RAFFAELE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1476 | EUCTR2005-000365-19-SK (EUCTR) | 23/06/2006 | 05/05/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | Estonia;Hungary;Czech Republic;Slovakia;Greece;Finland;Ireland;Lithuania;Germany;United Kingdom;Sweden | ||
| 1477 | EUCTR2005-001567-55-DE (EUCTR) | 23/06/2006 | 29/07/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United Kingdom;Germany;Spain | ||
| 1478 | NCT00648908 (ClinicalTrials.gov) | June 2006 | 28/3/2008 | Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial | Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial | Multiple Sclerosis | Drug: Fampridine-SR | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 269 | Phase 3 | United States;Canada |
| 1479 | NCT00355134 (ClinicalTrials.gov) | June 2006 | 19/7/2006 | Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | 24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase | Multiple Sclerosis | Drug: Fingolimod;Drug: Placebo | Novartis | NULL | Completed | 18 Years | 55 Years | All | 1083 | Phase 3 | United States;Australia;Austria;Canada;Poland;Romania;Turkey;United Kingdom;Lithuania |
| 1480 | EUCTR2006-000397-71-DK (EUCTR) | 16/05/2006 | 02/05/2006 | Double-blind, randomised, placebo-controlled trial of levetiracetam for central neuropathic pain in patients with multiple sclerosis - levetiracetam for central neuropathic pain in patients with multiple sclerosis | Double-blind, randomised, placebo-controlled trial of levetiracetam for central neuropathic pain in patients with multiple sclerosis - levetiracetam for central neuropathic pain in patients with multiple sclerosis | Trade Name: Keppra Product Name: Levetiracetam Product Code: ucb L059 | Søren H. Sindrup, Department of Neurology, Odense University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 30 | Denmark | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1481 | EUCTR2005-000365-19-DE (EUCTR) | 03/05/2006 | 25/01/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Hungary;Finland;Czech Republic;United Kingdom;Germany;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1482 | NCT00340834 (ClinicalTrials.gov) | May 2006 | 19/6/2006 | Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase | A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase | Multiple Sclerosis | Drug: Fingolimod 1.25 mg;Drug: Fingolimod 0.5 mg;Drug: Interferon ß-1a 30 µg | Novartis | NULL | Completed | 18 Years | 55 Years | All | 1292 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Egypt;France;Germany;Greece;Hungary;Italy;Korea, Republic of;Portugal;Spain;Switzerland;United Kingdom;Puerto Rico |
| 1483 | NCT00324506 (ClinicalTrials.gov) | May 2006 | 9/5/2006 | Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis | A Randomized, Open-label, Parallel-Group Multicenter Study to Determine the Safety/Efficacy of Mycophenolate Mofetil in Mono & Combination Therapy With Interferon Beta 1a in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Mycophenolate Mofetil (CellCept) | University of Texas Southwestern Medical Center | Aspreva Pharmaceuticals | Completed | 18 Years | 55 Years | Both | 43 | Phase 2 | United States |
| 1484 | NCT00331747 (ClinicalTrials.gov) | May 2006 | 30/5/2006 | Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate | Three Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer Acetate | Multiple Sclerosis | Drug: Glatiramer acetate | Sheba Medical Center | NULL | Recruiting | 18 Years | N/A | Both | 20 | N/A | Israel |
| 1485 | EUCTR2006-002562-19-IT (EUCTR) | 21/04/2006 | 24/01/2007 | Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT | Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT | VERIFICARE Patients with multiple sclerosis, age between 18 and 50 MedDRA version: 6.1;Level: PT;Classification code 10028245 | Trade Name: L04AA04 - IMMUNOGLOBULINA ANTITIMOCITARIA (DI CONIGLIO) IMMUNOGLOBULINA DI CONIGLIO ANTITIMOCITI UMANI THYMOGLOBULINE Product Name: Thymoglobuline INN or Proposed INN: Antithymocyte Trade Name: Endoxan - ciclofosfamide Product Name: Endoxan INN or Proposed INN: Cyclophosfamide | Dipartimento di Neuroscienze Oftalmologia e Genetica DINOG - Universita di Genova | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1486 | EUCTR2005-001540-23-SE (EUCTR) | 03/03/2006 | 12/09/2005 | A Scandinavian, randomized, rater-blinded study of single and double-dose (2x250 mcg e.o.d.) Betaferon in patients with early secondary progressive multiple sclerosis. - BECAUSE - Betaferon in Early SPMS - SCAndinavian study on USE of double dose | A Scandinavian, randomized, rater-blinded study of single and double-dose (2x250 mcg e.o.d.) Betaferon in patients with early secondary progressive multiple sclerosis. - BECAUSE - Betaferon in Early SPMS - SCAndinavian study on USE of double dose | Early Secondary Progressive Multiple Sclerosis | Trade Name: Betaferon Product Name: Betaferon Trade Name: Betaferon Product Name: Betaferon | Schering Nordiska AB | NULL | Not Recruiting | Female: yes Male: yes | 160 | Denmark;Sweden | |||
| 1487 | NCT00291148 (ClinicalTrials.gov) | March 2006 | 10/2/2006 | Neuropathic Pain Assessment Comparing Pregabalin and Paroxetine in Management of MS-induced Neuropathic Pain | A Comparative Single Center, Randomized Neuropathic Pain Assessment Study Involving Patients With Clinically Definite Multiple Sclerosis (MS) Receiving Treatment With Either Pregabalin or Paroxetine | Neuropathic Pain;Multiple Sclerosis | Drug: paroxetine;Drug: pregabalin;Drug: Paroxetine | University of Manitoba | NULL | Completed | 18 Years | 65 Years | Both | 75 | Phase 3 | Canada |
| 1488 | NCT00317941 (ClinicalTrials.gov) | March 2006 | 24/4/2006 | Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif | The AVANTAGE Study - A Randomized, Multicenter, Phase IV, Open-label Prospective Study Comparing Injection Site Reaction and Injection Site Pain in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) or After a First Demyelinating Event Suggestive of MS Newly Started on Interferon Beta-1b (Betaferon®) or Interferon Beta-1a (Rebif®). | Relapsing-remitting Multiple Sclerosis | Drug: Betaferon/Betaseron;Drug: Rebif | Bayer | NULL | Completed | 18 Years | 55 Years | All | 220 | Phase 4 | France |
| 1489 | EUCTR2005-000365-19-CZ (EUCTR) | 02/02/2006 | 11/01/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;United Kingdom;Czech Republic;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1490 | NCT01134627 (ClinicalTrials.gov) | February 2006 | 28/5/2010 | Minocycline as add-on to Interferon Beta-1a [IFN Beta-1a] (Rebif®) in Relapsing-Remitting Multiple Sclerosis [RRMS] | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline Versus Placebo as Add-on Therapy in Patients Who Are on Treatment With Interferon-beta-1a 44 Mcg Tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Minocycline;Drug: Placebo | Merck KGaA | NULL | Terminated | 18 Years | 55 Years | All | 305 | Phase 2 | Denmark |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1491 | EUCTR2005-004289-18-FI (EUCTR) | 26/01/2006 | 07/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Sweden | |||
| 1492 | EUCTR2005-003930-16-SE (EUCTR) | 19/01/2006 | 21/11/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 1493 | EUCTR2005-005211-21-FI (EUCTR) | 17/01/2006 | 07/12/2005 | A long term follow up of relapsing remitting multiple sclerosis patients who have been treated with intereron beta -1b (Betaferon) at least 5 years | A long term follow up of relapsing remitting multiple sclerosis patients who have been treated with intereron beta -1b (Betaferon) at least 5 years | Remitting relapsing multiple sclerosis (RRMS) is one of the most common diseases of the central nervous system. The cause of MS is not yet known but it is a result of damage to myelin. Symptoms vary widely and include blurred vision, weak limbs, tingling sensations, unsteadiness and fatigue. | Trade Name: Betaferon Product Name: Betaferon INN or Proposed INN: Beta-1b interferoni | Schering Oy | NULL | Not Recruiting | Female: yes Male: yes | 80 | Finland | |||
| 1494 | EUCTR2005-003930-16-FI (EUCTR) | 05/01/2006 | 29/11/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who have been prescribed treatment with Avonex. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Trade Name: Simvastatin Alternova Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 1495 | EUCTR2005-004289-18-SE (EUCTR) | 04/01/2006 | 10/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1496 | NCT00289978 (ClinicalTrials.gov) | January 2006 | 9/2/2006 | Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis | A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Fingolimod 1.25 mg;Drug: Fingolimod 0.5 mg;Drug: Placebo | Novartis | NULL | Completed | 18 Years | 55 Years | All | 1272 | Phase 3 | Australia;Belgium;Canada;Czech Republic;Finland;France;Germany;Greece;Israel;Lithuania;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Sweden;Switzerland;Turkey;United Kingdom;Italy |
| 1497 | NCT00280592 (ClinicalTrials.gov) | January 2006 | 20/1/2006 | Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients | Prospective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients. | Multiple Sclerosis;Urinary Tract Infections;Bladder Dysfunction | Drug: Cranberry;Drug: Placebo | Rennes University Hospital | Pierre Fabre Laboratories;Ministry of Health, France | Completed | 18 Years | 70 Years | Both | 171 | Phase 3 | France |
| 1498 | NCT00818103 (ClinicalTrials.gov) | January 2006 | 31/12/2008 | Characteristic Study on Chinese Patients With Multiple Sclerosis | Characteristic Study on Chinese Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: atorvastatin;Drug: ß-interferon;Drug: EPO | Sun Yat-sen University | Third Affiliated Hospital, Sun Yat-Sen University | Recruiting | N/A | 65 Years | Both | 600 | N/A | China |
| 1499 | EUCTR2005-000365-19-SE (EUCTR) | 19/12/2005 | 02/11/2005 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1500 | EUCTR2005-004289-18-DK (EUCTR) | 19/12/2005 | 28/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | E. Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Denmark;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1501 | EUCTR2005-001540-23-DK (EUCTR) | 15/12/2005 | 20/10/2005 | A Scandinavian, randomized, rater-blinded study of single and double-dose (2x250 mcg e.o.d.) Betaferon in patients with early secondary progressive multiple sclerosis. - BECAUSE - Betaferon in Early SPMS - SCAndinavian study on USE of double dose | A Scandinavian, randomized, rater-blinded study of single and double-dose (2x250 mcg e.o.d.) Betaferon in patients with early secondary progressive multiple sclerosis. - BECAUSE - Betaferon in Early SPMS - SCAndinavian study on USE of double dose | Early Secondary Progressive Multiple Sclerosis | Product Name: Betaferon Product Name: Betaferon | Schering Nordiska AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Denmark;Sweden | |||
| 1502 | EUCTR2005-001567-55-GB (EUCTR) | 14/12/2005 | 24/08/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 1503 | EUCTR2005-003930-16-DK (EUCTR) | 09/12/2005 | 05/12/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Denmark;Sweden | |||
| 1504 | NCT00241254 (ClinicalTrials.gov) | December 2005 | 17/10/2005 | Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple Sclerosis | A Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S Study | Multiple Sclerosis, Chronic Progressive | Drug: Cyclophosphamide (drug);Drug: Methylprednisolone (drug) | University Hospital, Bordeaux | Ministry of Health, France | Completed | 18 Years | 65 Years | Both | 138 | Phase 3 | France |
| 1505 | NCT00273364 (ClinicalTrials.gov) | November 16, 2005 | 5/1/2006 | Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study | Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Multiple Sclerosis | Procedure: Hematopoietic Stem Cell Therapy;Drug: Standard treatment with a conventional drug | Northwestern University | Uppsala University;Sheffield Teaching Hospitals NHS Foundation Trust;University of Sao Paulo | Completed | 18 Years | 55 Years | All | 110 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1506 | NCT00313976 (ClinicalTrials.gov) | November 2005 | 11/4/2006 | Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS) | A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) | Bayer | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | Denmark;Sweden |
| 1507 | EUCTR2005-001567-55-ES (EUCTR) | 18/10/2005 | 05/09/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 2 | United Kingdom;Germany;Spain | ||
| 1508 | EUCTR2005-001567-55-AT (EUCTR) | 27/09/2005 | 23/08/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 1509 | NCT00220506 (ClinicalTrials.gov) | September 2005 | 14/9/2005 | Fatigue Treatment Using Provigil | Fatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple Sclerosis | All Multiple Sclerosis Patients | Drug: Provigil | Sheba Medical Center | NULL | Recruiting | 18 Years | 55 Years | Both | 50 | N/A | Israel |
| 1510 | EUCTR2005-006071-12-IT (EUCTR) | 31/08/2005 | 09/05/2006 | Evaluation of efficacy, safety and tolerability of an ADd-on therapy with Cianocabalamine Vitamin B12 plus Calcium levofolinate in relapsing-remitting multiple sclerosis patients Already in treatment with Nterferon beta over a period of 24 months for a better lonterm outComE - ADVANCE | Evaluation of efficacy, safety and tolerability of an ADd-on therapy with Cianocabalamine Vitamin B12 plus Calcium levofolinate in relapsing-remitting multiple sclerosis patients Already in treatment with Nterferon beta over a period of 24 months for a better lonterm outComE - ADVANCE | MULTIPLE SCLEROSIS MedDRA version: 6.1;Level: PT;Classification code 10028245 | Trade Name: EPARMEFOLIN 30 CPR 0,1/0,5MG INN or Proposed INN: CALCIO FOLINATO DC.IT INN or Proposed INN: CIANOCOBALAMINA FU DC.IT Trade Name: LEVOFOLENE 4 MG 30 CPR INN or Proposed INN: Calcium levofolinate | AZIENDA OSPEDALIERA SAN CAMILLO FORLANINI | NULL | Not Recruiting | Female: yes Male: yes | 276 | Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1511 | NCT00915577 (ClinicalTrials.gov) | August 2005 | 5/6/2009 | Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe | An Open-Label, Multicenter Study to Determine Subject Satisfaction in Using the Single-Use Autoinjector With a Pre-Filled Liquid AVONEX® Syringe in Multiple Sclerosis Subjects | Multiple Sclerosis | Drug: Interferon beta-1a;Device: Single-use autoinjector | Biogen Idec | NULL | Completed | 18 Years | 65 Years | Both | 74 | Phase 3 | NULL |
| 1512 | EUCTR2004-002567-24-HU (EUCTR) | 19/07/2005 | 06/04/2005 | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicable | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicable | The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS). | Product Name: MLN1202 Product Code: MLN1202 INN or Proposed INN: Not yet available Other descriptive name: Not yet available | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2a | Hungary;United Kingdom;Czech Republic | ||
| 1513 | EUCTR2005-001009-25-IT (EUCTR) | 16/07/2005 | 15/03/2006 | Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with Relapsing-remitting multIple sclerosis in treAtment with INterferoN-betA. - ARIANNA | Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with Relapsing-remitting multIple sclerosis in treAtment with INterferoN-betA. - ARIANNA | Multiple sclerosis treatment MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TORVAST*10CPR 10MG INN or Proposed INN: Atorvastatin Trade Name: TORVAST*10CPR 10MG INN or Proposed INN: Atorvastatin | DR DIMENSIONE RICERCA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1514 | NCT00202423 (ClinicalTrials.gov) | July 2005 | 12/9/2005 | Use of Cannabinoids in Patients With Multiple Sclerosis | fMRI and Neurophysiological Study Protocol on Cannabinoids in Multiple Sclerosis | Multiple Sclerosis | Drug: Sativex | S. Andrea Hospital | University of Roma La Sapienza | Recruiting | 18 Years | 60 Years | Both | 20 | Phase 2 | Italy |
| 1515 | NCT00122954 (ClinicalTrials.gov) | July 2005 | 20/7/2005 | Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis | Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis | Multiple Sclerosis;Depression | Drug: Fish oil concentrate;Drug: Placebo | Oregon Health and Science University | National Center for Complementary and Integrative Health (NCCIH) | Completed | 18 Years | 85 Years | All | 39 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1516 | NCT01142518 (ClinicalTrials.gov) | July 2005 | 10/6/2010 | An Observational Study of Multiple Sclerosis (MS) Patients Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation Treatment With Mitoxantrone | A Prospective Analysis of MS Patients After Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation Treatment | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon beta 1a | Merck KGaA | NULL | Completed | N/A | N/A | Both | 86 | N/A | NULL |
| 1517 | NCT00202397 (ClinicalTrials.gov) | June 2005 | 12/9/2005 | Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar Ataxia | Phase 2 Study of Riluzole Effects on Patients With Chronic Cerebellar Ataxia | Hereditary Ataxia;Multiple Sclerosis;Cerebellar Ataxia | Drug: Riluzole;Other: placebo | S. Andrea Hospital | NULL | Completed | 18 Years | 80 Years | Both | 40 | Phase 2 | Italy |
| 1518 | NCT00463710 (ClinicalTrials.gov) | June 2005 | 19/4/2007 | Effect of Interferon Beta-1a (Avonex®) on Changes of Non-Conventional MRI Measures in Patients With MS | Effect of Interferon Beta-1a (Avonex®) on Changes of Non-Conventional MRI Measures in Patients With Relapsing-Remitting and Secondary-Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Avonex® monotherapy (6.0 MIU administered i.m. each week) | State University of New York at Buffalo | Biogen Idec | Completed | 18 Years | 65 Years | Both | 150 | United States | |
| 1519 | NCT01450488 (ClinicalTrials.gov) | June 2005 | 6/10/2011 | Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis | A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: masitinib | AB Science | NULL | Completed | 18 Years | 60 Years | All | 35 | Phase 2 | NULL |
| 1520 | NCT00094172 (ClinicalTrials.gov) | May 2005 | 14/10/2004 | Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Atorvastatin in Patients With Clinically Isolated Syndrome and High Risk of Conversion to Multiple Sclerosis (ITN020AI) | Multiple Sclerosis | Drug: Atorvastatin;Drug: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Completed | 18 Years | 55 Years | All | 82 | Phase 2 | United States;Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1521 | NCT00942591 (ClinicalTrials.gov) | May 2005 | 17/7/2009 | Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b | Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis. | Multiple Sclerosis | Drug: Interferon beta 1b;Drug: Atorvastatin | University Hospital Inselspital, Berne | CRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil;Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel | Completed | 18 Years | 55 Years | Both | 77 | Phase 2 | Switzerland |
| 1522 | NCT01142453 (ClinicalTrials.gov) | May 2005 | 10/6/2010 | An Observational Study Evaluating Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in Multiple Sclerosis (MS) Patients | Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in MS Patients. Case Series for Adjustment of Treatment Strategy and Its Monitoring | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon beta 1a | Merck KGaA | Gesellschaft für Therapieforschung mbH | Completed | N/A | N/A | Both | 231 | N/A | NULL |
| 1523 | NCT01199640 (ClinicalTrials.gov) | May 2005 | 9/9/2010 | Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis | Multiple Sclerosis | Drug: MLN1202 | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | Both | 50 | Phase 2 | NULL |
| 1524 | EUCTR2004-002567-24-CZ (EUCTR) | 04/04/2005 | 04/02/2005 | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcable | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcable | The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS). | Product Name: MLN1202 Product Code: MLN1202 INN or Proposed INN: Not yet available Other descriptive name: Not yet available | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2a | Hungary;United Kingdom;Czech Republic | ||
| 1525 | NCT00109161 (ClinicalTrials.gov) | April 2005 | 22/4/2005 | Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody) | PDL BioPharma, Inc. | NULL | Completed | 18 Years | 55 Years | Both | 270 | Phase 2 | United States;Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1526 | NCT00668343 (ClinicalTrials.gov) | April 2005 | 27/4/2008 | Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo | Relapsing Remitting Multiple Sclerosis | Drug: simvastatin;Drug: placebo | Tehran University of Medical Sciences | NULL | Completed | 15 Years | 60 Years | Both | 80 | Phase 3 | Iran, Islamic Republic of | |
| 1527 | NCT00146159 (ClinicalTrials.gov) | March 2005 | 1/9/2005 | Study Evaluating Mitoxantrone in Multiple Sclerosis | A Double-Blind, Three-Armed, Randomized Phase-III-Study, to Compare the Efficacy, Tolerability and Safety of Three Doses of Mitoxantrone in the Treatment of Patients With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Drug: Mitoxantrone | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Terminated | 18 Years | 55 Years | Both | 336 | Phase 3 | Germany |
| 1528 | NCT00211887 (ClinicalTrials.gov) | January 2005 | 13/9/2005 | Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx | A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx) | Relapsing Remitting Multiple Sclerosis | Drug: Interferon beta 1-a;Drug: glatiramer acetate;Other: placebo | Fred Lublin | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | 60 Years | All | 1008 | Phase 3 | United States;Canada |
| 1529 | NCT01201343 (ClinicalTrials.gov) | January 2005 | 13/9/2010 | Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients | Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients | Multiple Sclerosis, Relapsing, Remitting | Drug: Interferon beta-1a | Merck KGaA | Merck Serono S.A.S, France | Completed | 18 Years | N/A | All | 79 | Phase 4 | NULL |
| 1530 | NCT00206635 (ClinicalTrials.gov) | January 2005 | 9/9/2005 | Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis | A Long-term Follow up of Patients Enrolled in the Pivotal Study of Betaseron® (Interferon Beta 1b) in Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 33 Years | N/A | Both | 432 | N/A | United States;Canada;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1531 | NCT01142492 (ClinicalTrials.gov) | January 2005 | 10/6/2010 | A Postmarketing Surveillance (PMS) Study to Evaluate the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis (MS) With Interferon Beta 1a (Rebif®) | Postmarketing Surveillance Study on the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis With Interferon Beta 1a (Rebif®) | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon beta-1a | Merck KGaA | NULL | Completed | N/A | N/A | Both | 403 | N/A | NULL |
| 1532 | NCT00869726 (ClinicalTrials.gov) | December 2004 | 24/3/2009 | A Study for Patients With Secondary Progressive Multiple Sclerosis | A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Drug: dirucotide;Drug: Placebo | Eli Lilly and Company | BioMS Technology Corp. | Completed | 18 Years | 65 Years | Both | 596 | Phase 2;Phase 3 | Canada;Denmark;Estonia;Finland;Germany;Latvia;Netherlands;Spain;Sweden;United Kingdom |
| 1533 | EUCTR2004-001601-10-IT (EUCTR) | 19/11/2004 | 15/03/2007 | MULTICENTTRIC, NATIONAL, SINGLE BLIND,CONTROLLED IN PARALLEL GROUP TO EVALUATE THE SAFETY AND EFFICACY OF THE SEQUENTIAL COMBINATION OF MITOXANTRONE AND BETA INTERFERON REBIF 44 mcg X 3 TIMES WEEKLY IN PATIENTS AFFECTED BY MULTIPLE SCLEROSIS, IN THE FIRST STEP OF THE DISEASE | MULTICENTTRIC, NATIONAL, SINGLE BLIND,CONTROLLED IN PARALLEL GROUP TO EVALUATE THE SAFETY AND EFFICACY OF THE SEQUENTIAL COMBINATION OF MITOXANTRONE AND BETA INTERFERON REBIF 44 mcg X 3 TIMES WEEKLY IN PATIENTS AFFECTED BY MULTIPLE SCLEROSIS, IN THE FIRST STEP OF THE DISEASE | MULTIPLE SCLEROSIS TREATMENT MedDRA version: 6.1;Level: SOC;Classification code 10029205 | Trade Name: NOVANTRONE*INF 2MG/ML 5ML INN or Proposed INN: Mitoxantrone Trade Name: REBIF*SC 12SIR 12000000UI44MCG INN or Proposed INN: Interferon beta-1a | OSPEDALE S. RAFFAELE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 266 | France;Italy | |||
| 1534 | EUCTR2004-000663-99-HU (EUCTR) | 08/11/2004 | 08/09/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Sweden | |||
| 1535 | EUCTR2004-000663-99-CZ (EUCTR) | 12/10/2004 | 22/10/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Czech Republic;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1536 | EUCTR2005-000393-47-IT (EUCTR) | 22/09/2004 | 05/03/2007 | Effect of Cannabis Based Medicine Extract Sativex on brain function as assessed by fMRI and neurophysiologic evaluation in patients with Multiple Sclerosis a double blind, randomised, placebo-controlled, crossover study. | Effect of Cannabis Based Medicine Extract Sativex on brain function as assessed by fMRI and neurophysiologic evaluation in patients with Multiple Sclerosis a double blind, randomised, placebo-controlled, crossover study. | Treatment of spasticity in patients with Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Cannabis Based Medicine Extract (Sativex) | AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1537 | EUCTR2004-000663-99-SE (EUCTR) | 10/09/2004 | 03/08/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Sweden | |||
| 1538 | EUCTR2004-000073-64-FI (EUCTR) | 03/09/2004 | 14/07/2004 | A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Effects of L-000124467 on Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis as Measured by MRI. Satunnaistettu, kaksoissokkoutettu ja lumekontrolloitu rinnakkaisryhmin etenevä tutkimus, jossa tutkitaan L-000124467 -lääkkeen kliinistä tehoa, turvallissuutta ja siedettävyyttä aaltomaista MS-tautia sairastavilla potilailla MRI menetelmällä. - - | A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Effects of L-000124467 on Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis as Measured by MRI. Satunnaistettu, kaksoissokkoutettu ja lumekontrolloitu rinnakkaisryhmin etenevä tutkimus, jossa tutkitaan L-000124467 -lääkkeen kliinistä tehoa, turvallissuutta ja siedettävyyttä aaltomaista MS-tautia sairastavilla potilailla MRI menetelmällä. - - | Aaltomainen MS-tauti | Merck & Co., Inc./Suomen MSD Oy | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Finland | |||
| 1539 | NCT00315367 (ClinicalTrials.gov) | September 2004 | 14/4/2006 | A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties | A Double-Blind, Crossover Trial of Aricept® in Memory-Impaired Patients With Multiple Sclerosis: A Phase IV Demonstration of Functional MRI (fMRI) as a Surrogate Marker of Brain Activity Associated With Improvement in Memory Function | Relapsing-Remitting Multiple Sclerosis | Drug: Donepezil HCI (drug) | Neurognostics | NULL | Completed | 18 Years | 65 Years | Both | 26 | Phase 4 | United States |
| 1540 | NCT00097331 (ClinicalTrials.gov) | September 2004 | 22/11/2004 | Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis | A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Three Months Administration of SB-683699 (150 - 1200mg Twice Daily) in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: SB683699 | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | Both | 261 | Phase 2 | Belgium;Germany;Poland;Russian Federation;Spain;United States;Canada;France;Italy;Romania |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1541 | NCT00134563 (ClinicalTrials.gov) | September 2004 | 23/8/2005 | Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 1088 | Phase 3 | United States;Austria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 1542 | NCT00239655 (ClinicalTrials.gov) | August 2004 | 13/10/2005 | A Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by Magnetic Resonance Imaging (MRI)(0812-003)(COMPLETED) | A Randomized, Double-Blind Placebo Controlled, Parallel Groups Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by MRI | Relapsing-Remitting Multiple Sclerosis | Drug: MK0812 | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | 55 Years | Both | 120 | Phase 2 | Canada;Finland;Germany;United Kingdom;United States |
| 1543 | NCT00103974 (ClinicalTrials.gov) | July 2004 | 17/2/2005 | Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis | A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: BHT-3009-01 | Bayhill Therapeutics | NULL | Completed | 18 Years | 65 Years | Both | 30 | Phase 1 | United States;Canada |
| 1544 | NCT00207727 (ClinicalTrials.gov) | July 2004 | 13/9/2005 | A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis | A Phase II, Double-blind, Placebo-Controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40(CNTO1275) in Subjects With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: CNTO 1275 | Centocor, Inc. | Centocor BV | Completed | 18 Years | 65 Years | All | 249 | Phase 2 | Australia;Canada;Czech Republic;Hungary;Poland;United Kingdom;United States |
| 1545 | NCT00202995 (ClinicalTrials.gov) | July 2004 | 13/9/2005 | Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS | A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Betaseron;Drug: Rebif | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 50 Years | Both | 91 | Phase 4 | United States;Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1546 | NCT00223301 (ClinicalTrials.gov) | July 2004 | 19/9/2005 | Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis | A One-Year Prospective, Randomized, Placebo-Controlled, Double-Blind, Phase II/III Safety Trial of Combination Therapy With IFN Beta-1a (Avonex) and Mycophenolate Mofetil (Cellcept) in Early Multiple Sclerosis | Multiple Sclerosis | Drug: Mycophenolate Mofetil (cellcept) | University of Texas Southwestern Medical Center | Roche Pharma AG;Biogen Idec | Completed | 21 Years | 45 Years | Both | 24 | Phase 2;Phase 3 | United States |
| 1547 | NCT00493077 (ClinicalTrials.gov) | May 2004 | 25/6/2007 | Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy | A Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta Therapy | Multiple Sclerosis | Drug: low immunogenic interferon-beta-1a | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 3 | Phase 4 | Sweden |
| 1548 | NCT01233245 (ClinicalTrials.gov) | April 2004 | 14/10/2010 | BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program | BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program | Relapsing Remitting MS (RRMS);Secondary Progressive MS (SPMS) | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 1077 | N/A | Czech Republic;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Lebanon;Netherlands;Portugal;Saudi Arabia;Spain;Taiwan;Turkey |
| 1549 | NCT00246324 (ClinicalTrials.gov) | December 2003 | 27/10/2005 | Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis | An Open Label Trial of Safety and Efficacy of Combination Therapy With Interferon-B-1a and Oral Doxycycline in Patients With Relapsing-remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: Interferon beta 1a, oral doxycycline | Louisiana State University Health Sciences Center Shreveport | Biogen | Completed | 18 Years | 55 Years | All | 16 | Phase 4 | United States |
| 1550 | NCT00099502 (ClinicalTrials.gov) | November 2003 | 15/12/2004 | BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients | International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily. | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046);Drug: Copaxone | Bayer | NULL | Completed | 18 Years | 55 Years | Both | 2244 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1551 | NCT00654927 (ClinicalTrials.gov) | November 2003 | 4/4/2008 | Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis | Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Fampridine-SR b.i.d. (Twice Daily) | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 177 | Phase 3 | United States;Canada |
| 1552 | NCT00493116 (ClinicalTrials.gov) | October 2003 | 25/6/2007 | Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta | A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 20 | Phase 4 | Australia;New Zealand |
| 1553 | NCT00276341 (ClinicalTrials.gov) | August 2003 | 12/1/2006 | Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive Impairment in Patients With Multiple Sclerosis | Efficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study. | Multiple Sclerosis, Relapsing-Remitting | Drug: EGb 761® (Tanakan®) | Ipsen | NULL | Completed | 18 Years | N/A | All | 240 | Phase 3 | France |
| 1554 | NCT00202982 (ClinicalTrials.gov) | August 2003 | 12/9/2005 | A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose | A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis Patients | Relapse-Remitting Multiple Sclerosis | Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 40 mg | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 90 | Phase 2 | United States |
| 1555 | NCT00079495 (ClinicalTrials.gov) | July 2003 | 8/3/2004 | Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of NBI-5788 in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: NBI-5788 | Neurocrine Biosciences | Immune Tolerance Network (ITN) | Completed | 18 Years | 55 Years | Both | 150 | Phase 2 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1556 | NCT00097760 (ClinicalTrials.gov) | June 2003 | 30/11/2004 | Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis | Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA) | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab;Drug: Placebo | Biogen Idec | Elan Pharmaceuticals | Completed | 18 Years | 55 Years | Both | 110 | Phase 2 | NULL |
| 1557 | NCT00278655 (ClinicalTrials.gov) | June 2003 | 16/1/2006 | Hematopoietic Stem Cell Therapy for Patients With Multiple Sclerosis | Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Interferon Therapy: A Phase II Multi-Center Trial | Multiple Sclerosis | Biological: Hematopoietic stem cell transplantation | Northwestern University | NULL | Terminated | 18 Years | 50 Years | All | 21 | Phase 1;Phase 2 | United States |
| 1558 | NCT00220493 (ClinicalTrials.gov) | June 2003 | 14/9/2005 | Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients | Clinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis;Multiple Sclerosis, Chronic Progressive | Drug: Ritalin | Sheba Medical Center | NULL | Recruiting | 25 Years | 65 Years | Both | 80 | Phase 1 | Israel |
| 1559 | NCT00235989 (ClinicalTrials.gov) | June 2003 | 10/10/2005 | Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis | An Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta 1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 55 Years | All | 63 | Phase 2 | United States |
| 1560 | NCT00095329 (ClinicalTrials.gov) | May 2003 | 2/11/2004 | Treating Multiple Sclerosis With Sirolimus, an Immune System Suppressor | A Phase I/II, Open-Label Pilot Trial to Evaluate the Safety of Rapamune (Sirolimus) in Patients With Multiple Sclerosis | Multiple Sclerosis (MS) - Relapsing-remitting | Biological: sirolimus | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Terminated | 18 Years | 58 Years | Both | 14 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1561 | NCT00333138 (ClinicalTrials.gov) | May 2003 | 1/6/2006 | Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis | Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase | Multiple Sclerosis | Drug: FTY720;Drug: Placebo | Novartis | NULL | Completed | 18 Years | 60 Years | All | 281 | Phase 2 | Canada;Denmark;Finland;France;Germany;Italy;Poland;Portugal;Spain;Switzerland;United Kingdom |
| 1562 | NCT00206648 (ClinicalTrials.gov) | March 2003 | 13/9/2005 | An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS | A Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With Avonex | Multiple Sclerosis, Relapsing-Remitting | Drug: Betaferon/Betaseron | Bayer | NULL | Completed | 18 Years | 60 Years | Both | 271 | Phase 4 | United States;Canada |
| 1563 | NCT00492466 (ClinicalTrials.gov) | March 2003 | 25/6/2007 | Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies | A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 14 | Phase 4 | Finland |
| 1564 | NCT00298662 (ClinicalTrials.gov) | February 2003 | 2/3/2006 | Combination Therapy of Betaseron-Prograf in Multiple Sclerosis | A Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying Agents | Multiple Sclerosis | Drug: Interferon beta-1b and Tacrolimus | Clinique de sclérose en plaques et neuromusculaire de l'Outaouais | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 30 | Phase 2 | Canada |
| 1565 | NCT00053417 (ClinicalTrials.gov) | February 2003 | 29/1/2003 | Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis | Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP);Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP);Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP) | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 206 | Phase 2 | United States;Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1566 | NCT00210301 (ClinicalTrials.gov) | January 2003 | 13/9/2005 | Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MS | Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS | Relapsing-Remitting Multiple Sclerosis | Drug: Provigil (modafinil) | Institute for Clinical Research | NULL | Recruiting | 20 Years | 65 Years | Both | 60 | N/A | United States |
| 1567 | NCT00176592 (ClinicalTrials.gov) | January 2003 | 13/9/2005 | Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI | Phase IV, Rater-blinded, Randomized Study, Comparing 250 mg of Betaseron With 20 mg of Copaxone in Patients With the Relapsing-remitting(RR) or CIS Forms of ms Using 3 Tesla(3T) Magnetic Resonance Imaging (MRI) With Triple-dose Gadolinium | Multiple Sclerosis | Drug: Betaseron;Drug: Copaxone | Stuart D Cook MD | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 93 | Phase 4 | United States |
| 1568 | NCT00912860 (ClinicalTrials.gov) | January 2003 | 2/6/2009 | Immunogenicity and Safety Study of Serum-Free Avonex | A Multicenter, Open-Label Immunogenicity and Safety Study of a Serum-Free Pre-Formulated Solution of AVONEX (Interferon Beta-1a) Administered Intramuscularly to Patients With Relapsing/Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1a | Biogen Idec | NULL | Completed | 18 Years | 60 Years | Both | 155 | Phase 2 | NULL |
| 1569 | NCT00076934 (ClinicalTrials.gov) | January 2003 | 6/2/2004 | Safety of RG2077 in Patients With Multiple Sclerosis | A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: RG2077 (CTLA4-IgG4m) | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN);Repligen Corporation | Completed | 18 Years | 55 Years | All | 20 | Phase 1 | United States |
| 1570 | NCT00168766 (ClinicalTrials.gov) | January 2003 | 13/9/2005 | Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Interferon-beta-1a (Avonex) plus methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 345 | Phase 4 | Belgium;Denmark;Finland;Netherlands;Norway;Sweden;Switzerland;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1571 | NCT00050232 (ClinicalTrials.gov) | December 2002 | 2/12/2002 | Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients | Multiple Sclerosis | Drug: AVP-923 | Avanir Pharmaceuticals | NULL | Completed | 18 Years | 68 Years | Both | 96 | Phase 3 | United States | |
| 1572 | NCT00050778 (ClinicalTrials.gov) | December 2002 | 19/12/2002 | A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis | A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: Interferon beta-1a;Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg | Genzyme, a Sanofi Company | Bayer | Completed | 18 Years | 50 Years | All | 334 | Phase 2 | United States;Croatia;Poland;Russian Federation;United Kingdom |
| 1573 | NCT00220779 (ClinicalTrials.gov) | December 2002 | 13/9/2005 | Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis | Randomized, Double-Blind, Placebo-Controlled Study to Compare the Effects of Different Dose Regimens of IGIV Chromatography (IGIV-C), 10% Treatment on Relapses in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) | Grifols Therapeutics Inc. | NULL | Completed | 18 Years | 55 Years | All | 128 | Phase 2 | United States;Austria;Canada;Czech Republic;Germany;Greece;Hungary;Israel;Poland;Slovakia;Sweden;United Kingdom |
| 1574 | NCT00893217 (ClinicalTrials.gov) | November 2002 | 4/5/2009 | BEYOND Pilot Study | Double-blind, Randomized, Parallel Group, Multicenter Study of the Safety and Tolerability of Betaseron 500 Mcg Subcutaneously Every Other Day and Betaseron 250 Mcg Subcutaneously Every Other Day for at Least 12 Weeks in Patients With RRMS | Multiple Sclerosis;Relapsing-Remitting | Drug: Betaseron (Interferon beta-1b, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 55 Years | Both | 71 | Phase 2 | United States |
| 1575 | NCT00913666 (ClinicalTrials.gov) | November 2002 | 2/6/2009 | Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers | A Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX®, MS Subjects Naïve to Treatment, and Healthy Control Subjects | Multiple Sclerosis | Drug: Interferon beta-1a (Avonex) | Biogen Idec | NULL | Completed | 18 Years | 65 Years | Both | 121 | Phase 4 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1576 | NCT00678795 (ClinicalTrials.gov) | August 2002 | 14/5/2008 | A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis | A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Cannabis Based Medicine (CBM) Extract, in Patients Suffering Detrusor Overactivity Associated With Multiple Sclerosis. | Detrusor Overactivity;Multiple Sclerosis | Drug: Sativex®;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 135 | Phase 3 | United Kingdom |
| 1577 | NCT00185211 (ClinicalTrials.gov) | August 2002 | 9/9/2005 | BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study | Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months. | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 48 Years | All | 468 | Phase 3 | Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom |
| 1578 | NCT00047580 (ClinicalTrials.gov) | June 2002 | 8/10/2002 | Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity. | A Multicenter, Open-Label, Randomized, 4-Way Crossover Trial of the Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex (Tizanidine Hydrochloride) Tablets Taken Under Fed and Fasted Conditions in Patients With Moderate to Severe Spasticity | Multiple Sclerosis;Muscle Spasticity;Spinal Cord Injury;Stroke | Drug: tizanidine hydrochloride capsule | Elan Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 120 | Phase 3 | United States |
| 1579 | NCT00711646 (ClinicalTrials.gov) | June 2002 | 8/7/2008 | A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis. | A Double Blind, Randomised, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Cannabis Based Medicine 1:1 THC:CBD Compared With Placebo for the Treatment of Spasticity in Patients With Multiple Sclerosis. | Spasticity;Multiple Sclerosis | Drug: Sativex®;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 189 | Phase 3 | United Kingdom |
| 1580 | NCT00151801 (ClinicalTrials.gov) | May 2002 | 8/9/2005 | Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients | Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: estroprogestins;Drug: interferon-beta 1a | S. Andrea Hospital | NULL | Recruiting | 18 Years | 40 Years | Female | 200 | Phase 2 | Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1581 | NCT01448252 (ClinicalTrials.gov) | May 2002 | 5/10/2011 | T Cell Vaccination in Patients With Progressive Multiple Sclerosis | Autologous T Cell Vaccination With Line Specific for 9 Myelin Peptides in Patients With Progressive / Relapsing Multiple Sclerosis | Multiple Sclerosis | Biological: multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides);Biological: T cell vaccination | Hadassah Medical Organization | NULL | Completed | 18 Years | 60 Years | Both | 30 | Phase 1;Phase 2 | Israel |
| 1582 | NCT00037115 (ClinicalTrials.gov) | May 2002 | 15/5/2002 | Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event. | An Open Label Pilot Study of Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event: Comparison With CHAMPS Results. | Demyelinating Disorders;Multiple Sclerosis;Optic Neuritis;Myelitis;Neuritis | Drug: interferon beta 1a;Drug: methotrexate;Drug: methylprednisolone | MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute | Consultants in Neurology | Withdrawn | 18 Years | 50 Years | All | 0 | Phase 4 | United States |
| 1583 | NCT01606176 (ClinicalTrials.gov) | March 2002 | 21/5/2012 | A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological Origin | A Multi Centre Randomised, Double Blind, Placebo Controlled, Parallel Group Comparison of the Effects of Cannabis Based Medicine Standardised Extracts Over 4 Weeks, in Patients With Chronic Refractory Pain Due to Multiple Sclerosis or Other Defects of Neurological Function. | Pain;Multiple Sclerosis | Drug: GW-1000-02;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 70 | Phase 3 | United Kingdom |
| 1584 | NCT01606137 (ClinicalTrials.gov) | February 2002 | 21/5/2012 | A Study of the Long-term Safety of Sativex Use | A Long-term, Open Label, Safety and Tolerability Study of Cannabis Based Medicine Extract in Patients Who Have Participated in a GW Clinical Study Using Cannabis Based Medicine. | Multiple Sclerosis;Spasticity;Pain | Drug: GW-1000-02 | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 507 | Phase 3 | United Kingdom |
| 1585 | NCT00202410 (ClinicalTrials.gov) | November 2001 | 12/9/2005 | Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis | Phase 2-3 Use of Bacille Calmette-Guèrin (BCG) Vaccine in Patients With a First Clinical Demyelinating Episode: a Multicenter, Randomized, Single Blind Study. | Multiple Sclerosis | Biological: Bacille of Calmette-Guerin;Other: placebo | S. Andrea Hospital | Multiple Sclerosis Italian Foundation (FISM);Istituto Superiore di Sanità | Completed | 18 Years | N/A | Both | 80 | Phase 2;Phase 3 | Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1586 | NCT01610687 (ClinicalTrials.gov) | July 2001 | 31/5/2012 | A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis | A Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension | Multiple Sclerosis;Spasticity | Drug: GW-1000-02 | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 137 | Phase 3 | United Kingdom |
| 1587 | NCT01610700 (ClinicalTrials.gov) | May 2001 | 31/5/2012 | An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis Patients | Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension | Multiple Sclerosis | Drug: GW-1000-02;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 160 | Phase 3 | United Kingdom |
| 1588 | NCT01610713 (ClinicalTrials.gov) | May 2001 | 31/5/2012 | An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis | Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension | Multiple Sclerosis | Drug: GW-1000-02 | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 154 | Phase 3 | United Kingdom |
| 1589 | NCT00017628 (ClinicalTrials.gov) | April 2001 | 6/6/2001 | Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: cyclophosphamide;Drug: filgrastim;Drug: methylprednisolone;Procedure: Autologous Stem Cell Transplantation | Northwestern Memorial Hospital | NULL | Completed | N/A | 59 Years | Both | 20 | Phase 1 | United States | |
| 1590 | NCT00534261 (ClinicalTrials.gov) | November 1999 | 21/9/2007 | Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a? | Evaluation of the Correlation Between the MS Functional Composite Index and Two Quality of Life Scales (MS54 and AMS Quality of Life) in Relapsing MS Patients Treated With Interferon Beta-1a (AVONEX®) | Relapsing Remitting Multiple Sclerosis | Drug: Interferon beta-1a | Biogen Idec | NULL | Completed | 18 Years | 70 Years | Both | 284 | Phase 4 | Belgium;Luxembourg;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1591 | NCT00062972 (ClinicalTrials.gov) | September 1999 | 18/6/2003 | Improving Memory in Patients With Multiple Sclerosis | Interventions to Improve Memory in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: donepezil;Drug: glucose | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | U.S. Department of Education | Withdrawn | 18 Years | 56 Years | All | 0 | Phase 3 | United States |
| 1592 | NCT00006060 (ClinicalTrials.gov) | April 1999 | 5/7/2000 | Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: standard gadolinium contrast | National Center for Research Resources (NCRR) | University of Pennsylvania | Recruiting | 20 Years | 70 Years | Both | 100 | N/A | United States | |
| 1593 | NCT00040482 (ClinicalTrials.gov) | April 1999 | 26/6/2002 | High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple Sclerosis | Intensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Cyclophosphamide;Drug: ATG;Drug: MESNA;Procedure: Radiation therapy | Baylor College of Medicine | The Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of Medicine | Completed | 18 Years | 60 Years | All | 10 | Phase 2 | United States |
| 1594 | NCT00001781 (ClinicalTrials.gov) | February 1998 | 3/11/1999 | Safety, Tolerability, and Effectiveness of CGP77116 in Patients With Multiple Sclerosis (MS) | Open-Label Baseline vs. Treatment Trial Evaluating the Safety, Tolerability and Effect on MRI Lesion and Immunology Parameters of CGP 77116 in Patients With Multiple Sclerosis Mark | Multiple Sclerosis | Drug: CGP 77116 | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 25 | Phase 2 | United States |
| 1595 | NCT01257958 (ClinicalTrials.gov) | February 1998 | 8/12/2010 | Vitamin D Pilot Study in Patients With Multiple Sclerosis | Vitamin D Pilot Study in Patients With Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: 19 nor vitamin d | University of Wisconsin, Madison | NULL | Completed | 18 Years | 45 Years | Both | Phase 1 | United States | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1596 | NCT00014755 (ClinicalTrials.gov) | December 1997 | 10/4/2001 | Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: filgrastim;Drug: prednisone;Procedure: peripheral blood stem cell transplantation;Procedure: irradiation | Fred Hutchinson Cancer Research Center | NULL | Completed | 18 Years | 60 Years | Both | 35 | Phase 1 | United States | |
| 1597 | NCT00001669 (ClinicalTrials.gov) | July 1997 | 3/11/1999 | A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients | A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients | Multiple Sclerosis | Drug: rhIGF-1 (CEP-151) | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 15 | Phase 2 | United States |
| 1598 | NCT00004816 (ClinicalTrials.gov) | July 1995 | 24/2/2000 | A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: monoclonal antibody M-T412 | National Center for Research Resources (NCRR) | Stanford University | Completed | 21 Years | 75 Years | Both | 25 | Phase 1 | NULL | |
| 1599 | NCT00203021 (ClinicalTrials.gov) | March 26, 1994 | 12/9/2005 | Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness | Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone | Relapsing-Remitting Multiple Sclerosis | Drug: Glatiramer acetate | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | N/A | All | 208 | Phase 4 | United States |
| 1600 | EUCTR2008-007015-32-DE (EUCTR) | 03/03/2009 | A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phase | A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phase | cognitive impairment in Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Exelon transdermales Pflaster Product Name: Exelon Product Code: ENA713 INN or Proposed INN: Rivastigmin Trade Name: Exelon transdermales Pflaster Product Name: Exelon Product Code: ENA713 INN or Proposed INN: Rivastigmin Trade Name: Exelon transdermales Pflaster Product Name: Exelon Product Code: ENA713 INN or Proposed INN: Rivastigmin Trade Name: Exelon transdermales Pflaster Product Name: Exelon Product Code: ENA713 INN or Proposed INN: Rivastigmin | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase A | Germany | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1601 | EUCTR2011-005249-12-IE (EUCTR) | 21/06/2016 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Portugal;United States;Estonia;Slovenia;Morocco;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Tunisia;China;Bosnia and Herzegovina | |||
| 1602 | EUCTR2008-000499-25-DE (EUCTR) | 13/05/2008 | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMS | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMS | Relapsing forms of Multiple Sclerosis (RMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Rebif New Formulation 44mcg multidose cartridge INN or Proposed INN: INTERFERON BETA-1A | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3b | Germany;Spain;Italy;Sweden | |||
| 1603 | EUCTR2014-005624-98-EE (EUCTR) | 14/09/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Peru;South Africa;Netherlands;Kuwait;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany | |||
| 1604 | EUCTR2016-003100-30-PL (EUCTR) | 21/07/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway | |||
| 1605 | EUCTR2016-003100-30-Outside-EU/EEA (EUCTR) | 16/06/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 65 | Phase 3 | Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Greece;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1606 | EUCTR2017-005129-18-IT (EUCTR) | 26/03/2018 | Clinical trial to evaluate the effectiveness and safety of IFN beta-1a (IFN beta-1a), injected once a week via intramuscolar (i.m.), and glatiramer-acetate (GA) in children/adolescent patients with multiple sclerosis. | Multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN-beta-1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis. | Relapsing-remitting multiple sclerosis with paediatric onset MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 40 mg/ml solution for injection, pre-filled syringe INN or Proposed INN: Glatiramer Acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: AVONEX 30 µg/0,5 ml solution for injection INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Università degli Studi Aldo Moro | NULL | NA | Female: yes Male: yes | 142 | Phase 3 | Italy | |||
| 1607 | EUCTR2010-018705-11-DE (EUCTR) | 14/10/2010 | A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ONO-4641/ MSC2430913A Product Code: ONO-4641/ MSC2430913A Product Name: ONO-4641/ MSC2430913A Product Code: ONO-4641/ MSC2430913A Product Name: ONO-4641/ MSC2430913A Product Code: ONO-4641/ MSC2430913A | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 376 | United States;Czech Republic;Greece;Canada;Spain;Belgium;Ukraine;Russian Federation;Germany;Japan | ||||
| 1608 | EUCTR2006-005270-47-DE (EUCTR) | 09/02/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3b | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | |||
| 1609 | EUCTR2007-002627-32-DE (EUCTR) | 26/05/2008 | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Gilenya 0,5 mg Hartkapseln Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Sweden | ||||
| 1610 | EUCTR2011-005249-12-FR (EUCTR) | 17/06/2015 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis - TERIKIDS | Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 165 | Phase 3 | Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;China | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1611 | EUCTR2016-003100-30-BG (EUCTR) | 02/06/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway | |||
| 1612 | EUCTR2015-000137-78-AT (EUCTR) | 17/09/2015 | Mesenchymal stem cells therapy for patients with multiple sclerosis | Randomised, double-blind, cross-over phase II study with intravenous autologous mesenchymal stem cells vs. placebo for multiple sclerosis patients in Austria (MESEMS Austria) | multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Human autologous mesenchymal stem cells INN or Proposed INN: MSC2015 Other descriptive name: UNDIFFERENTIATED AUTOLOGOUS MESENCHYMAL STEM CELLS | SALK - Gemeinnützige Salzburger Landeskliniken Betriebsges. m.b.H., Christian-Doppler-Klinik, UK für Neurologie der PMU | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Austria | ||||
| 1613 | EUCTR2011-005249-12-Outside-EU/EEA (EUCTR) | 10/05/2016 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 165 | Phase 3 | Tunisia;Turkey;United States;Australia;Bosnia and Herzegovina;Canada;China;Israel;Lebanon;Morocco;Russian Federation | |||
| 1614 | EUCTR2012-003056-36-NL (EUCTR) | 21/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Netherlands;Latvia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 1615 | EUCTR2011-005249-12-BG (EUCTR) | 13/01/2017 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 165 | Phase 3 | United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1616 | EUCTR2016-003100-30-FR (EUCTR) | 17/07/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 1617 | EUCTR2011-001692-39-DE (EUCTR) | 08/06/2011 | A study to evaluate the safety and tolerability of the combination of an antidepressive therapy with oral fingolimod in the treatment of relapsing remitting multiple sclerosis patients with mild to moderate depression | A 21-week, multicenter, open label study to evaluate the safety and tolerability profile of the combination of a SSRI or SNRI antidepressive therapy with oral fingolimod in the treatment of RRMS patients with mild to moderate depression | Multiple SclerosisDepression MedDRA version: 14.1;Level: PT;Classification code 10012378;Term: Depression;System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Gilenya Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Venlafaxin Hexal Product Name: Venlafaxin Hexal Other descriptive name: VENLAFAXINE HYDROCHLORIDE Trade Name: Fluoxetin Hexal Product Name: Fluoxetin Hexal INN or Proposed INN: FLUOXETINE HYDROCHLORIDE Trade Name: Venlafaxin Hexal Product Name: Venlafaxin Hexal Other descriptive name: VENLAFAXINE HYDROCHLORIDE Trade Name: Fluoxetin Hexal Product Name: Fluoxetin Hexal INN or Proposed INN: FLUOXETINE HYDROCHLORIDE Trade Name: Gilenya Product Name: Gilenya Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | |||||
| 1618 | EUCTR2009-014724-32-DE (EUCTR) | 26/10/2010 | Boswellic Acids in Multiple Sclerosis | SAFETY, TOLERABILITY AND MECHANISM OF ACTION OF BOSWELLIC ACIDS (BA) IN MULTIPLE SCLEROSIS (MS) AND CLINICALLY ISOLATED SYNDROME (CIS): A MRI-CONTROLLED, MULTICENTER, BASELINE-TO-TREATMENT, 32-WEEKS, OPEN-LABEL, PHASE IIA TRIAL IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS OR CLINICALLY ISOLATED SYNDROME - SABA | Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | University Medical Center Eppendorf | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Germany | ||||
| 1619 | EUCTR2014-004613-93-Outside-EU/EEA (EUCTR) | 12/01/2015 | Open label study to evaluate effect, safety and tolerability of Betaferon standard dose of 250µg in patients of Chinese origin with multiple sclerosis | Open label study to evaluate the effect, safety and tolerability of 250µg (8 MIU) interferon beta 1b (Betaferon) given subcutaneously every other day (for 24 weeks) in patients of Chinese origin with multiple sclerosis | Multiple sclerosis MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaseron Product Code: BAY86-5046 INN or Proposed INN: INTERFERON BETA-1B | Bayer HealthCare AG | NULL | NA | Female: yes Male: yes | 35 | China | ||||
| 1620 | EUCTR2014-005624-98-AT (EUCTR) | 17/09/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Peru;South Africa;Netherlands;Kuwait;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 1621 | EUCTR2008-008719-25-DE (EUCTR) | 16/02/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Name: BAF312 Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Finland;Germany;Spain;Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04244006 (ClinicalTrials.gov) | July 23, 2020 | 13/1/2020 | A Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton Syndrome | A Randomized Double-blinded Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton Syndrome | Netherton Syndrome | Drug: Dupilumab Prefilled Syringe;Other: Placebo Prefilled Syringe | University Hospital, Toulouse | MedSharing | Recruiting | 18 Years | N/A | All | 24 | Phase 2;Phase 3 | France |
| 2 | EUCTR2019-001220-35-FR (EUCTR) | 08/10/2019 | 23/04/2019 | A pilot study of the efficacy and safety of dupilumab versus placebo in patients with Netherton syndrome | A randomized double-blinded pilot study of the efficacy and safety of dupilumab versus placebo in patients with Netherton syndrome - NS-Dupi | Netherton syndrome MedDRA version: 20.0;Level: PT;Classification code 10062909;Term: Netherton's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | CHU de Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | France | |||
| 3 | NCT02864082 (ClinicalTrials.gov) | March 8, 2017 | 3/8/2016 | A Safety and Tolerability Study of Topical PAT-001 in Congenital Ichthyosis | A Randomized, Bilateral Comparison, Vehicle-Controlled, Safety and Tolerability Study of Topical PAT-001 for the Treatment of Congenital Ichthyosis | Congenital Ichthyosis | Drug: PAT-001, 0.1%;Drug: PAT-001, 0.2%;Drug: Vehicle | Patagonia Pharmaceuticals, LLC | NULL | Completed | 12 Years | N/A | All | 19 | Phase 2 | United States |
| 4 | NCT03041038 (ClinicalTrials.gov) | December 2016 | 17/1/2017 | The Efficacy and Safety of Secukinumab in Patients With Ichthyoses | A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Maintenance Dosing Period to Evaluate the Efficacy and Safety of Secukinumab in Patients With Ichthyoses | Ichthyosis;Autosomal Recessive Congenital Ichthyosis;Lamellar Ichthyosis;Congenital Ichthyosiform Erythroderma;Epidermolytic Ichthyosis;Netherton Syndrome | Drug: Secukinumab;Drug: Placebo | Northwestern University | Icahn School of Medicine at Mount Sinai | Completed | 18 Years | N/A | All | 21 | Phase 2 | United States |
| 5 | JPRN-jRCTs031180409 | 25/12/2013 | 22/03/2019 | Treatment of the genetic defect of cholesterol biosynthetic pathway. | Treatment of the genetic defect of cholesterol biosynthetic pathway by the topical application of statin and cholesterol. | CHILD syndrome, Conradi syndrome, porokeratosis, atopic dermatitis, psoriasis, seborrheic dermatitis Dermatitis and eczema | To patients, 1% atorvastatin/ 2% cholesterol lotion and/or 1% atorvastatin/ 2% cholesterol ointment, and/or 1% oxiconazole cream are topically applied on the skin. To healthy subjects, administration of atorvastatin or topical application of 1% atorvastatin/ 2% cholesterol is performed once to investigate drug metabolism. | Kubo Akiharu | NULL | Not Recruiting | Not applicable | Not applicable | Both | 158 | Phase 2 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2011-000917-38-NL (EUCTR) | 13/09/2013 | 09/07/2013 | CBPR277X2101 | A first–in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multiple topical administrations of BPR277 in patients with atopic dermatitis and Netherton syndrome | Part 2: Atopic Dermatitis (AD)Part 3: Netherton Syndrome (NS) MedDRA version: 14.1;Level: LLT;Classification code 10003639;Term: Atopic dermatitis;System Organ Class: 100000004858 MedDRA version: 14.1;Level: PT;Classification code 10062909;Term: Netherton's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BPR277 INN or Proposed INN: Not available Other descriptive name: BPR277 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 85 | Germany;Netherlands;France;United States | |||
| 7 | EUCTR2011-003212-22-GB (EUCTR) | 03/06/2013 | 08/03/2013 | A clinical trial to study the effects of genetically modified patients' skin stem cells | Phase I study of ex-vivo lentiviral gene therapy for the inherited skin disease Netherton Syndrome - Gene Therapy for Netherton Syndrome | Netherton Syndrome (NS) MedDRA version: 14.1;Level: PT;Classification code 10062909;Term: Netherton's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | GOSH/ICH Joint Research & Development Office | NULL | Not Recruiting | Female: yes Male: yes | 5 | Phase 1 | United Kingdom | |||
| 8 | EUCTR2011-000917-38-DE (EUCTR) | 14/09/2011 | 18/07/2011 | CBPR277X2101 | A first–in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multiple topical administrations of BPR277 in patients with atopic dermatitis and Netherton syndrome | Part 2: Atopic Dermatitis (AD)Part 3: Netherton Syndrome (NS) MedDRA version: 14.1;Level: LLT;Classification code 10003639;Term: Atopic dermatitis;System Organ Class: 100000004858 MedDRA version: 14.1;Level: PT;Classification code 10062909;Term: Netherton's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BPR277 INN or Proposed INN: not available Other descriptive name: BPR277 Product Code: BPR277 INN or Proposed INN: not available Other descriptive name: BPR277 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 85 | France;United States;Netherlands;Germany | |||
| 9 | EUCTR2011-001205-27-NL (EUCTR) | 04/08/2011 | 25/07/2011 | The effect of lipid lowering medication on lipid accumulation in patients with neutral lipid storage disease with muscle weakness. | The effect of fibrate therapy in two patients with neutral lipid storage disease with myopathy (NLSDM). - Fibrate Trail | Neutral lipid storage disease with myopathy MedDRA version: 13.1;Level: PT;Classification code 10007636;Term: Cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders MedDRA version: 13.1;Level: HLGT;Classification code 10013317;Term: Lipid metabolism disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 13.1;Classification code 10028641;Term: Myopathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Bezalip Retard Product Name: Bezalip Retard Product Code: RVG 18388 INN or Proposed INN: BEZAFIBRATE Other descriptive name: none | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: no | Netherlands | |||||
| 10 | NCT01527318 (ClinicalTrials.gov) | August 2011 | 16/1/2012 | The Effect of Fibrate Therapy in Two Patients With Neutral Lipid Storage Disease With Myopathy (NLSDM) | The Effect of Fibrate Therapy in Two Patients With Neutral Lipid Storage Disease With Myopathy (NLSDM) | Neutral Lipid Storage Disease | Drug: Fibrate treatment | Maastricht University Medical Center | NULL | Completed | 18 Years | 70 Years | Both | 6 | Phase 4 | Netherlands |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT01428297 (ClinicalTrials.gov) | May 2011 | 19/8/2011 | A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome | A First-In-human Study to Evaluate Safety and Tolerability of Topical BPR277 in Healthy Volunteers, and Proof of Concept (PoC) Studies to Evaluate the Safety, Tolerability, and Efficacy of Topical BPR277 in Patients With Atopic Dermatitis and Netherton Syndrome | Healthy Volunteers;Atopic Dermatitis;Netherton Syndrome | Drug: BPR277 ointment (controlled application);Drug: Placebo (Vehicle);Drug: BPR277 ointment;Drug: BPR277 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 12 | Phase 1 | United States;Netherlands;France;Germany |
| 12 | EUCTR2009-015895-87-NL (EUCTR) | 23/12/2009 | 01/10/2009 | Application of zileuton (Zyflo CR) in patients with Sjögren Larsson Syndrome - Zileuton in Sjögren Larsson Syndrome | Application of zileuton (Zyflo CR) in patients with Sjögren Larsson Syndrome - Zileuton in Sjögren Larsson Syndrome | Sjögren Larsson syndrome (SLS) is an autosomal recessive inherited neurometabolic disorder which is characterized by a clinical triad of congenital ichthyosis, spastic di- or tetraplegia and mental retardation. A disturbance of lipid metabolism due to deficiency of the microsomal fatty aldehyde dehydrogenase (FALDH) underlies SLS. | Trade Name: Zyflo CR Product Name: zileuton INN or Proposed INN: ZILEUTON Other descriptive name: lipoxygenase inhibitor | UMC St Radboud | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 13 | NCT00004690 (ClinicalTrials.gov) | September 1996 | 24/2/2000 | Phase III Study of Monolaurin Cream Therapy for Patients With Congenital Ichthyosis | Ichthyosis | Drug: monolaurin cream | Cellegy Pharmaceuticals | NULL | Completed | 2 Years | N/A | Both | 90 | Phase 3 | NULL |